Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure (GRAIL)
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ClinicalTrials.gov Identifier: NCT01335932
Recruitment Status :
Completed
First Posted : April 15, 2011
Results First Posted : September 13, 2017
Last Update Posted : August 21, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Michael Boeckh, Fred Hutchinson Cancer Research Center
Interventional
Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
Acute Lung Injury
Acute Respiratory Distress Syndrome
Respiratory Failure
Drug: IV Ganciclovir
Drug: Placebo
160
Go to
Recruitment Details
Pre-assignment Details
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Period Title:
Overall Study
Started
84
76
Completed
84
72
Not Completed
0
4
Go to
Arm/Group Title
IV Ganciclovir
Placebo
Total
Arm/Group Description
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Total of all reporting groups
Arm/Group Description
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Total of all reporting groups
Overall Number of Baseline Participants
84
76
160
Baseline Analysis Population Description
[Not Specified]
Baseline Analysis Population Description
[Not Specified]
Age, Continuous
Mean (Full Range)
Unit of measure: Years
Number Analyzed
84 participants
76 participants
160 participants
55.2
(18 to 95)
58.2
(18 to 95)
56.6
(18 to 95)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed
84 participants
76 participants
160 participants
Female
35
41.7%
36
47.4%
71
44.4%
Male
49
58.3%
40
52.6%
89
55.6%
Region of Enrollment
Measure Type: Number
Unit of measure: Participants
United States
Number Analyzed
84 participants
76 participants
160 participants
84
76
160
Go to
1.Primary Outcome
Title
Serum IL-6 Level
Description
Change between baseline and 14 days post-randomization between placebo...
Description
Change between baseline and 14 days post-randomization between placebo & ganciclovir groups
Time Frame
Baseline and Day 14
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: pg/mL
-0.79
(0.65)
-0.79
(0.69)
2.Secondary Outcome
Title
Number of Participants With CMV Reactivation at 28 Days in Plasma
Description
Number of participants in baseline negatives with CMV reactivation at ...
Description
Number of participants in baseline negatives with CMV reactivation at any level at day 28
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
77
67
Measure Type: Count of ParticipantsUnit of Measure: Participants
CMV viremia at any level
3
3.9%
23
34.3%
no CMV viremia at any level
74
96.1%
44
65.7%
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
.0001
Comments
[Not Specified]
Method
Fisher Exact
Comments
[Not Specified]
3.Secondary Outcome
Title
BAL Levels of IL-6
Description
Levels of IL-6 from BALs at 7 days post-randomization
Description
Levels of IL-6 from BALs at 7 days post-randomization
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
3
7
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
1.01
(0.78)
1.66
(1.26)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.31
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
4.Secondary Outcome
Title
Number of Participants With Organ System Failure at 14 Days
Description
Number of participants experiencing organ system failure at 14 days
Description
Number of participants experiencing organ system failure at 14 days
Time Frame
at 14 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Measure Type: Count of ParticipantsUnit of Measure: Participants
with organ failure
0
0.0%
2
2.8%
without organ failure
84
100.0%
70
97.2%
5.Secondary Outcome
Title
Number of Days Alive and Not in the ICU
Description
Number of ICU days alive and not in the ICU by day 28
Description
Number of ICU days alive and not in the ICU by day 28
Time Frame
by 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: days
10.02
(6.84)
10.97
(8.23)
6.Secondary Outcome
Title
CMV Disease
Description
Need to be biopsy-proven
Description
Need to be biopsy-proven
Time Frame
by 180 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Measure Type: Count of ParticipantsUnit of Measure: Participants
Biopsy proven CMV disease
0
0.0%
0
0.0%
No Biopsy proven CMV disease
84
100.0%
72
100.0%
7.Secondary Outcome
Title
Grade 3 AEs or Higher
Description
Number of patients with greater than one AE of grade 3 or more
Description
Number of patients with greater than one AE of grade 3 or more
Time Frame
by 35 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Measure Type: Count of ParticipantsUnit of Measure: Participants
number with AE greater than grade 3
11
13.1%
10
13.9%
number without AE greater than grade 3
73
86.9%
62
86.1%
8.Secondary Outcome
Title
SF-36 Health Survey
Description
Physical Component Summary of SF-36. The SF-36 consists of eight scale...
Description
Physical Component Summary of SF-36. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Time Frame
at 1 day post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
53
35
Mean (Standard Deviation)Unit of Measure: scores on a scale
36.37
(10.93)
35
(11.28)
9.Secondary Outcome
Title
Incidence of CMV Reactivation >1,000 IU Per mL at Day 28 in Plasma
Description
Number of participants with CMV reactivation >1,000 IU per mL at da...
Description
Number of participants with CMV reactivation >1,000 IU per mL at day 28 in plasma
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
77
67
Measure Type: Count of ParticipantsUnit of Measure: Participants
CMV viremia >1,000 copies per mL
0
0.0%
5
7.5%
No CMV viremia >1,000 copies per mL
77
100.0%
62
92.5%
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.006
Comments
[Not Specified]
Method
Fisher Exact
Comments
[Not Specified]
10.Secondary Outcome
Title
Incidence of CMV Reactivation at Any Level at 28 Days in Throat
Description
CMV reactivation in baseline negatives at any level at day 28 in throa...
Description
CMV reactivation in baseline negatives at any level at day 28 in throat
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
80
67
Measure Type: Count of ParticipantsUnit of Measure: Participants
CMV reactivation at any level at day 28 in throat
2
2.5%
6
9.0%
No CMV reactivation at any level at day 28in throa
78
97.5%
61
91.0%
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.14
Comments
[Not Specified]
Method
Fisher Exact
Comments
[Not Specified]
11.Secondary Outcome
Title
Incidence of CMV Reactivation >1,000 IU Per mL at 28 Days in Throat
Description
Number of participants with CMV reactivation >1,000 IU per mL at da...
Description
Number of participants with CMV reactivation >1,000 IU per mL at day 28 in throat
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
80
67
Measure Type: Count of ParticipantsUnit of Measure: Participants
CMV reactivation >1,000 in IU per mL
0
0.0%
1
1.5%
No CMV reactivation >1,000 IU per mL in throat
80
100.0%
66
98.5%
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.10
Comments
[Not Specified]
Method
Fisher Exact
Comments
[Not Specified]
12.Secondary Outcome
Title
CMV AUC in Blood
Description
CMV AUC in blood from day 0 to day 28
Description
CMV AUC in blood from day 0 to day 28
Time Frame
Day 0 to 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: IU*day/mL
0.11
(0.39)
0.39
(0.69)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.002
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
13.Secondary Outcome
Title
CMV AUC in Throat
Description
CMV AUC in Throat from day 0 to day 28
Description
CMV AUC in Throat from day 0 to day 28
Time Frame
Day 0 to 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: IU*day/mL
0.03
(0.14)
0.17
(0.52)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.03
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
14.Secondary Outcome
Title
CMV Peak Viral Load in Blood
Description
CMV Peak Viremia in blood at day 28
Description
CMV Peak Viremia in blood at day 28
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: log 10 IU/mL
0.24
(0.67)
0.89
(1.21)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
<0.0001
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
15.Secondary Outcome
Title
BAL Levels of IL-8
Description
Levels of IL-8 in BALs at day 7
Description
Levels of IL-8 in BALs at day 7
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
3
7
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
2.21
(0.66)
2.61
(1.22)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.73
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
16.Secondary Outcome
Title
BAL Levels of TNFa
Description
Levels of TNFa in BALs at day 7
Description
Levels of TNFa in BALs at day 7
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
3
7
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
0.18
(0)
0.46
(0.49)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.33
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
17.Secondary Outcome
Title
Plasma Levels of IL-6
Description
Plasma levels of IL-6.
Description
Plasma levels of IL-6.
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
75
57
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
0.87
(0.84)
0.92
(0.62)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.31
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
18.Secondary Outcome
Title
Plasma Levels of IL-8
Description
Levels of IL-8 in plasma at day 7
Description
Levels of IL-8 in plasma at day 7
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
75
57
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
1.38
(0.6)
1.38
(0.35)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.96
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
19.Secondary Outcome
Title
Plasma Levels of TNF a
Description
Plasma levels of TNF a at day 7.Cytokines are summarized on log 10 sca...
Description
Plasma levels of TNF a at day 7.Cytokines are summarized on log 10 scale. When logged value is negative, the raw value would be less than 1.
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
75
57
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
-0.07
(0.36)
-0.1
(0.35)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.63
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
20.Secondary Outcome
Title
Plasma Levels of TNF a
Description
Plasma levels of TNF a from day 0 to day 28
Description
Plasma levels of TNF a from day 0 to day 28
Time Frame
Day 0 to 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
Cytokines are summarized on a log 10 scale. When the logged value is negative, the raw value would be less than 1.
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
33
31
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
-0.06
(0.37)
-0.11
(0.27)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.51
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
21.Secondary Outcome
Title
Plasma Levels of IL-6
Description
Plasma levels of IL-6 at day 28
Description
Plasma levels of IL-6 at day 28
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
33
31
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
0.35
(0.51)
0.59
(0.7)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.12
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
22.Secondary Outcome
Title
Plasma Levels of IL-8
Description
Plasma levels of IL-8 at day 28
Description
Plasma levels of IL-8 at day 28
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
33
31
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
1.09
(0.46)
1.27
(0.46)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.13
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
23.Secondary Outcome
Title
Plasma Levels of Soluble ICAM-1
Description
Plasma levels of soluble ICAM-1 at day 28
Description
Plasma levels of soluble ICAM-1 at day 28
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
33
31
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
5.34
(0.19)
5.48
(0.22)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.008
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
24.Secondary Outcome
Title
Plasma Levels of Soluble ICAM-1
Description
Plasma levels of soluble ICAM-1 at day 7
Description
Plasma levels of soluble ICAM-1 at day 7
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
75
57
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
5.43
(0.21)
5.45
(0.31)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.64
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
25.Secondary Outcome
Title
Peak Plasma Levels of Soluble ICAM-1
Description
Peak Plasma levels of soluble ICAM-1 from day 0 to day 28
Description
Peak Plasma levels of soluble ICAM-1 from day 0 to day 28
Time Frame
Day 0 to 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
5.52
(0.2)
5.57
(0.27)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.24
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
26.Secondary Outcome
Title
Peak Plasma Levels of TNF-a
Description
Peak Plasma levels of TNF-a at day 28
Description
Peak Plasma levels of TNF-a at day 28
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
0.16
(0.3)
0.17
(0.36)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.76
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
27.Secondary Outcome
Title
Peak Plasma Levels of IL-10
Description
Peak Plasma levels of IL-10 at day 28
Description
Peak Plasma levels of IL-10 at day 28
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
0.88
(0.52)
0.82
(0.49)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.45
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
28.Secondary Outcome
Title
Peak Plasma Levels of IL-8
Description
Peak Plasma levels of IL-8 at day 28
Description
Peak Plasma levels of IL-8 at day 28
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
1.67
(0.65)
1.66
(0.44)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.92
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
29.Secondary Outcome
Title
Peak Plasma Levels of IL-6
Description
Peak Plasma levels of IL-6 at day 28
Description
Peak Plasma levels of IL-6 at day 28
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: log 10 pg/mL
1.57
(0.78)
1.56
(0.78)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.94
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
30.Secondary Outcome
Title
AUC Plasma Levels of IL-6
Description
AUC Plasma levels of IL-6 from day 0 to day 28
Description
AUC Plasma levels of IL-6 from day 0 to day 28
Time Frame
Day 0 to 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: IU*day/mL
0.68
(0.49)
0.75
(0.51)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.37
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
31.Secondary Outcome
Title
AUC Plasma Levels of IL-8
Description
AUC Plasma levels of IL-8 from day 0 to day 28
Description
AUC Plasma levels of IL-8 from day 0 to day 28
Time Frame
Day 0 to 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: IU*day/mL
1.15
(0.45)
1.13
(0.42)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.80
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
32.Secondary Outcome
Title
AUC Plasma Levels of IL-10
Description
AUC Plasma levels of IL-10 from day 0 to day 28
Description
AUC Plasma levels of IL-10 from day 0 to day 28
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: IU*day/mL
0.36
(0.36)
0.35
(0.38)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.93
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
33.Secondary Outcome
Title
AUC Plasma Levels of TNF-a
Description
AUC Plasma levels of TNF-a from day 0 to day 28
Description
AUC Plasma levels of TNF-a from day 0 to day 28
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: IU*day/mL
-0.14
(0.28)
-0.14
(0.25)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.93
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
34.Secondary Outcome
Title
AUC Plasma Levels of Soluble ICAM-1
Description
AUC Plasma levels of soluble ICAM-1 from day 0 to day 28
Description
AUC Plasma levels of soluble ICAM-1 from day 0 to day 28
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: IU*day/mL
4.78
(0.98)
4.65
(1.25)
Statistical Analysis 1
Statistical Analysis 1
Statistical Analysis Overview
Comparison Group Selection
IV Ganciclovir, Placebo
Comments
[Not Specified]
Type of
Statistical Test
Other
Comments
[Not Specified]
Statistical Test of Hypothesis
P-Value
0.45
Comments
[Not Specified]
Method
t-test, 2 sided
Comments
[Not Specified]
35.Secondary Outcome
Title
Length of Stay
Description
Hospital days alive and not hospitalized by day 180
Description
Hospital days alive and not hospitalized by day 180
Time Frame
by 180 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
55
47
Mean (Standard Deviation)Unit of Measure: days
145.13
(47.63)
145.94
(47.88)
36.Secondary Outcome
Title
Length of Stay
Description
Hospital days alive and not hospitalized by day 28
Description
Hospital days alive and not hospitalized by day 28
Time Frame
by 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
78
69
Mean (Standard Deviation)Unit of Measure: days
9.96
(8.52)
8.72
(8.24)
37.Secondary Outcome
Title
Organ System Failure at 28 Days
Description
Number of participants with organ system failure at 28 days
Description
Number of participants with organ system failure at 28 days
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Measure Type: Count of ParticipantsUnit of Measure: Participants
with organ failure
0
0.0%
2
2.8%
without organ failure
84
100.0%
70
97.2%
38.Secondary Outcome
Title
Duration of Mechanical Ventilation as Assessed by Ventilator Free Days
Description
Number of days of mechanical ventilation duration as assessed by venti...
Description
Number of days of mechanical ventilation duration as assessed by ventilator free days
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: days
18.71
(9.08)
15.97
(9.72)
39.Secondary Outcome
Title
Duration of Mechanical Ventilation as Assessed by Ventilator Days
Description
Number of days of mechanical ventilation duration as assessed by venti...
Description
Number of days of mechanical ventilation duration as assessed by ventilator days
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Mean (Standard Deviation)Unit of Measure: days
6.95
(6.16)
8.5
(7.17)
40.Secondary Outcome
Title
Bacteremia and/or Fungemia
Description
Number of participants with bacteremia and/or fungemia
Description
Number of participants with bacteremia and/or fungemia
Time Frame
at 28 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Measure Type: Count of ParticipantsUnit of Measure: Participants
with bacteremia and /or fungemia
15
17.9%
11
15.3%
without bacteremia and /or fungemia
69
82.1%
61
84.7%
41.Secondary Outcome
Title
Mortality
Description
Mortality at 60 days post randomization
Description
Mortality at 60 days post randomization
Time Frame
at 60 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Measure Type: Count of ParticipantsUnit of Measure: Participants
dead
13
15.5%
12
16.7%
alive
71
84.5%
60
83.3%
42.Secondary Outcome
Title
Mortality at 180 Days
Description
Mortality at 180 days post-randomization
Description
Mortality at 180 days post-randomization
Time Frame
at 180 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Measure Type: Count of ParticipantsUnit of Measure: Participants
dead
18
21.4%
19
26.4%
alive
66
78.6%
53
73.6%
43.Secondary Outcome
Title
SF-36 Functional Assessment Physical Component
Description
Physical Component Summary at 180 days post- randomization. The SF-36 ...
Description
Physical Component Summary at 180 days post- randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Time Frame
at 180 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
40
34
Mean (Standard Deviation)Unit of Measure: scores on a scale
35.51
(11.38)
38.17
(10.96)
44.Secondary Outcome
Title
SF-36 Functional Assessment Mental Component
Description
Mental Component Summary at 180 days post-randomization. The SF-36 con...
Description
Mental Component Summary at 180 days post-randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Time Frame
at 180 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
40
34
Mean (Standard Deviation)Unit of Measure: scores on a scale
45.55
(11.52)
44.08
(12.25)
45.Secondary Outcome
Title
SF-36 Functional Assessment Mental Component on Day 1
Description
SF-36 Mental Component Summary at 1 day post-randomization. The SF-36 ...
Description
SF-36 Mental Component Summary at 1 day post-randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Time Frame
at 1 day post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
53
35
Mean (Standard Deviation)Unit of Measure: scores on a scale
43.83
(12)
42.73
(13.78)
46.Secondary Outcome
Title
Patients With Serious Adverse Events
Description
Number of patients with Serious Adverse Events by day 35
Description
Number of patients with Serious Adverse Events by day 35
Time Frame
by 35 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Measure Type: Count of ParticipantsUnit of Measure: Participants
Number of patients with a Serious adverse event
0
0.0%
0
0.0%
Number of patients without a Serious adverse event
84
100.0%
72
100.0%
47.Secondary Outcome
Title
Time to Neutropenia
Description
Time to neutropenia by 35 days post-randomization
Description
Time to neutropenia by 35 days post-randomization
Time Frame
by 35 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Measure Type: NumberUnit of Measure: days
0
0
48.Secondary Outcome
Title
Use of Granulocyte-colony Stimulating Factor
Description
Number of participants requiring Granulocyte-colony stimulating factor
Description
Number of participants requiring Granulocyte-colony stimulating factor
Time Frame
by 35 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Measure Type: Count of ParticipantsUnit of Measure: Participants
Number of patients that required GCSF
0
0.0%
0
0.0%
Number of patients that did not require GCSF
84
100.0%
72
100.0%
49.Secondary Outcome
Title
Renal Insufficiency
Description
Number of patients experiencing a glomerular filtration rate < 60mL...
Description
Number of patients experiencing a glomerular filtration rate < 60mL/min at day 35
Time Frame
by 35 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Measure Type: Count of ParticipantsUnit of Measure: Participants
Glomerular filtration rate less than 60 mL/min
36
42.9%
41
56.9%
Glomerular filtration rate greater than 60 mL/min
48
57.1%
31
43.1%
50.Secondary Outcome
Title
Red Blood Cell Transfusions Required Per Patients
Description
Red blood cell transfusions required per patients by day 35
Description
Red blood cell transfusions required per patients by day 35
Time Frame
by 35 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Median (Inter-Quartile Range)Unit of Measure: transfusions
2
(1 to 2)
1
(1 to 4)
51.Secondary Outcome
Title
Platelet Transfusions
Description
Platelet transfusions per patient
Description
Platelet transfusions per patient
Time Frame
by 35 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
721
Median (Inter-Quartile Range)Unit of Measure: transfusions
1
(1 to 1)
1
(1 to 2)
52.Secondary Outcome
Title
Clinical Outcomes
Description
Composite of survival status and >7 days ventilation status, and IL...
Description
Composite of survival status and >7 days ventilation status, and IL-6 levels. In the composite analysis, the endpoint is composed by death, ventilation status and change of cytokine.
Time Frame
at 14 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
84
72
Measure Type: Count of ParticipantsUnit of Measure: Participants
Number of patients with composite endpoint
42
50.0%
49
68.1%
Number of patients without composite endpoint
42
50.0%
23
31.9%
53.Secondary Outcome
Title
Bacteremia and Fungemia Outcomes
Description
Bacteremia and fungemia outcomes among subjects who survive at least 7...
Description
Bacteremia and fungemia outcomes among subjects who survive at least 7 days
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
82
64
Measure Type: NumberUnit of Measure: events
number of events
15
9
number of no events
67
55
54.Secondary Outcome
Title
Bacteremia and Fungemia Outcomes in Mechanically Ventilated Subjets
Description
Bacteremia and fungemia events among subjects who are mechanically ven...
Description
Bacteremia and fungemia events among subjects who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame
at 7 through 14 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
30
33
Measure Type: NumberUnit of Measure: events
number of events
6
9
number of no events
24
24
55.Secondary Outcome
Title
Overall Mortality
Description
Overall mortality amongst subjects who survive at least 7 days after r...
Description
Overall mortality amongst subjects who survive at least 7 days after randomization
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
82
64
Measure Type: NumberUnit of Measure: events
number of deaths
16
11
number of alive
66
53
56.Secondary Outcome
Title
Number of Mechanical Ventilated Days
Description
Number of mechanical ventilated days amongst subjects who survive at l...
Description
Number of mechanical ventilated days amongst subjects who survive at least 7 days after randomization
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
82
64
Mean (Standard Deviation)Unit of Measure: days
7.05
(6.19)
9.05
(7.4)
57.Secondary Outcome
Title
Number of Ventilator-free Days
Description
Number of ventilator-free days amongst subjects who survive at least 7...
Description
Number of ventilator-free days amongst subjects who survive at least 7 days after randomization
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
82
64
Mean (Standard Deviation)Unit of Measure: days
19.17
(8.7)
17.97
(8.37)
58.Secondary Outcome
Title
Number of Days in the ICU
Description
Number of days in the ICU amongst subjects who survive at least 7 days...
Description
Number of days in the ICU amongst subjects who survive at least 7 days after randomization
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
82
64
Mean (Standard Deviation)Unit of Measure: days
10.20
(6.82)
11.83
(8.32)
59.Secondary Outcome
Title
Number of ICU-free Days
Description
Number of ICU-free days amongst subjects who survive at least 7 days a...
Description
Number of ICU-free days amongst subjects who survive at least 7 days after randomization
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
82
64
Mean (Standard Deviation)Unit of Measure: days
15.38
(27)
13.89
(25)
60.Secondary Outcome
Title
Number of Days in the Hospital
Description
Number of days in the hospital amongst subjects who survive at least 7...
Description
Number of days in the hospital amongst subjects who survive at least 7 days after randomization
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
67
57
Mean (Standard Deviation)Unit of Measure: days
6.21
(4.85)
5.53
(4.9)
61.Secondary Outcome
Title
Number of Hospital-free Days
Description
Number of hospital-free days amongst subjects who survive at least 7 d...
Description
Number of hospital-free days amongst subjects who survive at least 7 days after randomization
Time Frame
at 7 days post-randomization
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
76
61
Mean (Standard Deviation)Unit of Measure: days
10.22
(8.47)
9.87
(8.09)
62.Secondary Outcome
Title
Mortality Among Subjects Mechanically Ventilated From Day 7 to 14
Description
Mortality among subjects by day 28 who are mechanically ventilated for...
Description
Mortality among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame
28 days
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
30
33
Measure Type: NumberUnit of Measure: events
number of events
9
6
number of no events
21
27
63.Secondary Outcome
Title
Number of Mechanically Ventilated Days Among Subjects by Day 28
Description
Number of mechanically ventilated days among subjects by day 28 who ar...
Description
Number of mechanically ventilated days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame
28 days
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
30
33
Mean (Standard Deviation)Unit of Measure: days
13.4
(6.12)
14.42
(6.64)
64.Secondary Outcome
Title
Number of Ventilator-free Days Among Subjects by Day 28
Description
Number of ventilator-free days among subjects by day 28 who are mechan...
Description
Number of ventilator-free days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame
28 days
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
30
33
Mean (Standard Deviation)Unit of Measure: days
11.4
(8.29)
12.45
(7.26)
65.Secondary Outcome
Title
Number of Days in ICU Amongst Subjects by Day 28
Description
Number of days in ICU amongst subjects by day 28 who are mechanically ...
Description
Number of days in ICU amongst subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame
28 days
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
30
33
Mean (Standard Deviation)Unit of Measure: days
16.73
(5.75)
17.79
(7.41)
66.Secondary Outcome
Title
Number of ICU-free Days Amongst Subjects by Day 28
Description
Number of ICU-free days amongst subjects by day 28 who are mechanicall...
Description
Number of ICU-free days amongst subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame
28 days
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
30
33
Mean (Standard Deviation)Unit of Measure: days
7.73
(18)
8.15
(18)
67.Secondary Outcome
Title
Number of Hospital-free Days Among Subjects by Day 28
Description
Number of hospital-free days among subjects by day 28 who are mechanic...
Description
Number of hospital-free days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization
Time Frame
28 days
Outcome Measure Data Outcome Measure Data
Analysis Population Description
Analysis Population Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description :
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description :
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
Overall Number of Participants Analyzed
28
32
Mean (Standard Deviation)Unit of Measure: days
3.54
(5.15)
4.59
(5.55)
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Time Frame
Clinical adverse events were collected from day 1(start of study drug) through day 35 (7 days after the stop of study drug).
Adverse Event Reporting Description
[Not Specified]
Arm/Group Title
IV Ganciclovir
Placebo
Arm/Group Description
5mg/kg IV twice daily for 5 days, t...
normal saline IV twice daily for 5 ...
Arm/Group Description
5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.
IV Ganciclovir
Placebo
Affected / at Risk (%)
Affected / at Risk (%)
Total
10/84 (11.90%)
11/72 (15.28%)
IV Ganciclovir
Placebo
Affected / at Risk (%)
Affected / at Risk (%)
Total
0/84 (0.00%)
0/72 (0.00%)
Frequency Threshold for Reporting Other Adverse Events
0%
IV Ganciclovir
Placebo
Affected / at Risk (%)
Affected / at Risk (%)
Total
0/84 (0.00%)
0/72 (0.00%)
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Inclusion of too few trauma patients to assess treatment effects, a long enrollment window length, discontinuation of BAL sampling due to feasibility and changes in oral drug availability (later part of the study)
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Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Name/Title:
Dr.Michael Boeckh
Organization:
FHCRC
Phone:
206 667-6706
Limaye AP, Stapleton RD, Peng L, Gunn SR, Kimball LE, Hyzy R, Exline MC, Files DC, Morris PE, Frankel SK, Mikkelsen ME, Hite D, Enfield KB, Steingrub J, O'Brien J, Parsons PE, Cuschieri J, Wunderink RG, Hotchkin DL, Chen YQ, Rubenfeld GD, Boeckh M. Effect of Ganciclovir on IL-6 Levels Among Cytomegalovirus-Seropositive Adults With Critical Illness: A Randomized Clinical Trial. JAMA. 2017 Aug 22;318(8):731-740. doi: 10.1001/jama.2017.10569.
Responsible Party:
Michael Boeckh, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01335932
History of Changes
Other Study ID Numbers:
7217
U01HL102547 ( U.S. NIH Grant/Contract )
First Submitted:
April 13, 2011
First Posted:
April 15, 2011
Results First Submitted:
June 21, 2017
Results First Posted:
September 13, 2017
Last Update Posted:
August 21, 2018