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Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells (MoxiProph)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00398411
Recruitment Status : Completed
First Posted : November 10, 2006
Results First Posted : December 11, 2013
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Oliver Cornely, MD, University of Cologne

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Hodgkin Disease
Non-Hodgkin Lymphoma
Multiple Myeloma
Bacteremia
Interventions Drug: moxifloxacin
Drug: placebo
Enrollment 66
Recruitment Details First patient in: Oct 10, 2006; Last patient, last visit: Dec 08, 2008
Pre-assignment Details 68 patients were intended for inclusion in the trial. Two patients were excluded due to violation of inclusion/exclusion criteria; both received no study drug and they were excluded from the analysis. The remaining 66 participants were evaluable for response analysis in the intention to treat (ITT) set.
Arm/Group Title Moxifloxacin Placebo
Hide Arm/Group Description moxifloxacin 400 mg tablets once daily identical appearing placebo
Period Title: Overall Study
Started 34 32
Completed 34 31
Not Completed 0 1
Reason Not Completed
Death             0             1
Arm/Group Title Moxifloxacin Placebo Total
Hide Arm/Group Description moxifloxacin 400 mg tablets once daily identical appearing placebo Total of all reporting groups
Overall Number of Baseline Participants 34 32 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants 32 participants 66 participants
54
(21 to 68)
50
(23 to 70)
51.5
(21 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
Female
14
  41.2%
11
  34.4%
25
  37.9%
Male
20
  58.8%
21
  65.6%
41
  62.1%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 34 participants 32 participants 66 participants
172.71  (8.7) 173.72  (9.7) 173.2  (9.1)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 34 participants 32 participants 66 participants
76.41  (13.9) 75.00  (16.5) 75.73  (15.1)
Underlying Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
Hodgkin's Disease 4 5 9
NHL 14 14 28
Multiple Myeloma 16 12 28
Solid Tumor 0 1 1
Status of Underlying Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
primary 20 14 34
primary progressive 3 3 6
relapsed 11 15 26
1.Primary Outcome
Title Incidence of Clinically Significant Bacteremia
Hide Description

Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary.

With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant.

Time Frame end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Moxifloxacin Placebo
Hide Arm/Group Description:
moxifloxacin 400 mg tablets once daily
identical appearing placebo
Overall Number of Participants Analyzed 34 32
Measure Type: Number
Unit of Measure: participants
3 9
2.Secondary Outcome
Title Type of Isolates and Infections
Hide Description [Not Specified]
Time Frame end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Moxifloxacin Placebo
Hide Arm/Group Description:
moxifloxacin 400 mg tablets once daily
identical appearing placebo
Overall Number of Participants Analyzed 34 32
Measure Type: Number
Unit of Measure: participants
bacteremia isolate: enterococcus faecalis 0 2
bacteremia isolate: escherichia coli 1 3
bacteremia isolate: klebsiella pneumoniae 0 1
bacteremia isolate: pseudomonas aeruginosa 1 0
bacteremia isolate: staphylococcus aureus 1 1
bacteremia isolate: staphylococcus epidermidis 0 1
bacteremia isolate: streptococcus species 0 1
clostridium difficile infection 1 1
mucositis 0 1
3.Secondary Outcome
Title Time to Occurrence of Fever >= 38°C
Hide Description [Not Specified]
Time Frame end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Moxifloxacin Placebo
Hide Arm/Group Description:
moxifloxacin 400 mg tablets once daily
identical appearing placebo
Overall Number of Participants Analyzed 34 32
Mean (Standard Deviation)
Unit of Measure: days
9.50  (4.1) 7.69  (3.1)
4.Secondary Outcome
Title Reason for Discontinuation of Treatment
Hide Description Absolute neutrophil count (ANC) recovered to > 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever >= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason
Time Frame end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Moxifloxacin Placebo
Hide Arm/Group Description:
moxifloxacin 400 mg tablets once daily
identical appearing placebo
Overall Number of Participants Analyzed 34 32
Measure Type: Number
Unit of Measure: participants
recovery of absolute neutrophil count 6 0
maximum of 20 days of treatment 0 0
premature discontinuation: occurence of fever 18 23
premature discontinuation: antibiotic treatment 1 1
premature discontinuation: death 0 1
premature discontinuation: other adverse event 6 2
premature discontinuation: other reason 3 5
5.Secondary Outcome
Title Type of Infection
Hide Description [Not Specified]
Time Frame follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Moxifloxacin Placebo
Hide Arm/Group Description:
moxifloxacin 400 mg tablets once daily
identical appearing placebo
Overall Number of Participants Analyzed 34 32
Measure Type: Number
Unit of Measure: participants
peri-anal abscess 0 1
mucositis 1 1
pulmonary infiltrate 1 0
infection at venous catheter 1 1
herpes infection 8 8
candida infection 1 0
acute respiratory syndrome 1 0
clostridium difficile infection 0 1
atypical pneumonia 0 1
6.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Moxifloxacin Placebo
Hide Arm/Group Description:
moxifloxacin 400 mg tablets once daily
identical appearing placebo
Overall Number of Participants Analyzed 34 32
Measure Type: Number
Unit of Measure: participants
34 31
Time Frame Adverse events (AE) have been documented throughout study duration, serious adverse events (SAE) until 4 weeks after end of study.
Adverse Event Reporting Description

The following AE have been documented in the trial but are not reported in this section unless as SAE:

Infections, already reported as outcome measures.

Expected AE as defined in the protocol: leukopenia, anemia, thrombocytopenia, including their manifestations; hepatosplenomegaly, bone pain, increase of lactate dehydrogenase, hyperuricemia.

 
Arm/Group Title Moxifloxacin Placebo
Hide Arm/Group Description moxifloxacin 400 mg tablets once daily identical appearing placebo
All-Cause Mortality
Moxifloxacin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Moxifloxacin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/34 (5.88%)      3/32 (9.38%)    
Cardiac disorders     
cardiac arrest *  0/34 (0.00%)  0 1/32 (3.13%)  1
Hepatobiliary disorders     
cholecystitis *  1/34 (2.94%)  1 0/32 (0.00%)  0
Infections and infestations     
atypical pneumonia   1/34 (2.94%)  1 0/32 (0.00%)  0
clostridium difficile infection   0/34 (0.00%)  0 1/32 (3.13%)  1
staphyloccocus epidermidis sepsis   0/34 (0.00%)  0 1/32 (3.13%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Moxifloxacin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/34 (100.00%)      32/32 (100.00%)    
Blood and lymphatic system disorders     
increase of CRP   8/34 (23.53%)  8 4/32 (12.50%)  4
Gastrointestinal disorders     
constipation *  8/34 (23.53%)  8 7/32 (21.88%)  7
diarrhea *  26/34 (76.47%)  36 21/32 (65.63%)  23
heartburn / reflux *  6/34 (17.65%)  6 2/32 (6.25%)  2
nausea *  31/34 (91.18%)  52 24/32 (75.00%)  42
vomiting *  24/34 (70.59%)  32 20/32 (62.50%)  32
General disorders     
abdominal cramps *  2/34 (5.88%)  2 1/32 (3.13%)  1
edema *  26/34 (76.47%)  37 26/32 (81.25%)  42
headache *  10/34 (29.41%)  13 10/32 (31.25%)  11
hypokalemia   25/34 (73.53%)  35 22/32 (68.75%)  28
hyponatremia   3/34 (8.82%)  3 2/32 (6.25%)  2
Hepatobiliary disorders     
increase of bilirubin   3/34 (8.82%)  4 2/32 (6.25%)  4
increase of liver enzymes   10/34 (29.41%)  20 13/32 (40.63%)  25
Infections and infestations     
fever   27/34 (79.41%)  35 31/32 (96.88%)  45
Musculoskeletal and connective tissue disorders     
back pain *  2/34 (5.88%)  2 1/32 (3.13%)  1
cramps in the calf *  1/34 (2.94%)  1 2/32 (6.25%)  2
Renal and urinary disorders     
dysuria *  2/34 (5.88%)  2 3/32 (9.38%)  3
increase of creatinine   0/34 (0.00%)  0 2/32 (6.25%)  2
Respiratory, thoracic and mediastinal disorders     
cough *  5/34 (14.71%)  5 6/32 (18.75%)  6
Skin and subcutaneous tissue disorders     
exanthema *  7/34 (20.59%)  7 6/32 (18.75%)  6
pruritus *  0/34 (0.00%)  0 2/32 (6.25%)  2
Vascular disorders     
hypertension   2/34 (5.88%)  2 3/32 (9.38%)  4
hypotension   3/34 (8.82%)  3 7/32 (21.88%)  7
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Dr. Oliver A. Cornely
Organization: University of Cologne
Phone: +49 221 478 88794
EMail: oliver.cornely@zks-koeln.de
Layout table for additonal information
Responsible Party: Oliver Cornely, MD, University of Cologne
ClinicalTrials.gov Identifier: NCT00398411    
Other Study ID Numbers: 05001
2005-003271-21 ( EudraCT Number )
First Submitted: November 8, 2006
First Posted: November 10, 2006
Results First Submitted: August 5, 2013
Results First Posted: December 11, 2013
Last Update Posted: June 29, 2015