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Use of a Loading Dose of Vancomycin in Pediatric Dosing

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ClinicalTrials.gov Identifier: NCT01290237
Recruitment Status : Terminated (PI leaving institution, slow enrollment)
First Posted : February 4, 2011
Results First Posted : March 5, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Alicia Demirjian, Boston Children’s Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Infection
Intervention Drug: vancomycin hydrocloride
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vancomycin Loading Dose Control
Hide Arm/Group Description

Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours

intravenous vancomycin hydrochloride: see description of study arms

Intravenous vancomycin 20 mg/kg/dose every 8 hours

intravenous vancomycin hydrochloride: see description of study arms

Period Title: Overall Study
Started 30 29
Completed 19 27
Not Completed 11 2
Arm/Group Title Vancomycin Loading Dose Control Total
Hide Arm/Group Description

Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours

intravenous vancomycin hydrochloride: see description of study arms

Intravenous vancomycin 20 mg/kg/dose every 8 hours

intravenous vancomycin hydrochloride: see description of study arms

Total of all reporting groups
Overall Number of Baseline Participants 30 29 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 29 participants 59 participants
8.63  (4.4) 8.76  (4.04) 8.70  (4.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 59 participants
Female
12
  40.0%
15
  51.7%
27
  45.8%
Male
18
  60.0%
14
  48.3%
32
  54.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 29 participants 59 participants
30 29 59
1.Primary Outcome
Title Count of Participants With Vancomycin Trough Between 15 and 20
Hide Description proportion of participants whose vancomycin trough was between 15 and 20 mcg/mL, 8 hours after the first vancomycin dose, in loading dose group as compared to control group
Time Frame 8 hours after the first dose of vancomycin
Hide Outcome Measure Data
Hide Analysis Population Description
Loading dose - trough at 8 hours was not collected for 11 participants: vancomycin was discontinued prior to second dose (7), participant changed their mind (1), other reason (3) Among participants allocated to conventional treatment, trough at 8 hours was not collected for 2: vancomycin discontinued prior to second dose (1), changed mind (1)
Arm/Group Title Vancomycin Loading Dose Control
Hide Arm/Group Description:

Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours

intravenous vancomycin hydrochloride: see description of study arms

Intravenous vancomycin 20 mg/kg/dose every 8 hours

intravenous vancomycin hydrochloride: see description of study arms

Overall Number of Participants Analyzed 19 27
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.5%
0
   0.0%
2.Secondary Outcome
Title AUC/MIC for Vancomycin in the Study Population
Hide Description AUC/MIC using hypothetical MIC = 1 mg/L
Time Frame within 48 hours after receiving the first dose of vancomycin
Hide Outcome Measure Data
Hide Analysis Population Description
Number of measurements reflects the number of participants with blood samples available for testing
Arm/Group Title Loading Dose Conventional Dose
Hide Arm/Group Description:
As above
as above
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: AUC/MIC ratio
446.5  (195.5) 434.0  (153.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vancomycin Loading Dose Control
Hide Arm/Group Description

Intravenous vancomycin 30 mg/kg/dose once, followed 8 hours later by 20 mg/kg/dose every 8 hours

intravenous vancomycin hydrochloride: see description of study arms

Intravenous vancomycin 20 mg/kg/dose every 8 hours

intravenous vancomycin hydrochloride: see description of study arms

All-Cause Mortality
Vancomycin Loading Dose Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/29 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Vancomycin Loading Dose Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      0/29 (0.00%)    
Renal and urinary disorders     
acute kidney injury [1]  1/30 (3.33%)  1 0/29 (0.00%)  0
[1]
One patient with cystic fibrosis developed acute kidney injury 7 days after administration of a conventional dose while receiving concomitant nephrotoxic medications; renal function recovered when these medications and vancomycin were discontinued.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vancomycin Loading Dose Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/30 (66.67%)      11/29 (37.93%)    
General disorders     
Escalation of care within 7 days   2/30 (6.67%)  2 3/29 (10.34%)  3
Renal and urinary disorders     
Doubling of baseline creatinine   4/30 (13.33%)  4 1/29 (3.45%)  1
Skin and subcutaneous tissue disorders     
Red man syndrome   14/30 (46.67%)  14 7/29 (24.14%)  7
Indicates events were collected by systematic assessment
  • trial underpowered to detect an increase of ≥40% in concentrations (small sample size)
  • more cases excluded in the high-dose group than in reference group (possible analysis bias)
  • increase in red man syndrome in the high-dose group
Certain Agreements
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.
Results Point of Contact
Name/Title: Dr. Alicia Demirjian
Organization: Boston Children's Hospital
Responsible Party: Alicia Demirjian, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT01290237     History of Changes
Other Study ID Numbers: 10-11-0561
First Submitted: January 28, 2011
First Posted: February 4, 2011
Results First Submitted: April 15, 2017
Results First Posted: March 5, 2018
Last Update Posted: June 19, 2018