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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oliver Cornely, MD, University of Cologne
ClinicalTrials.gov Identifier:
NCT00398411
First received: November 8, 2006
Last updated: October 16, 2013
Last verified: October 2013
Results First Received: August 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Conditions: Hodgkin Disease
Non-Hodgkin Lymphoma
Multiple Myeloma
Bacteremia
Interventions: Drug: moxifloxacin
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient in: Oct 10, 2006; Last patient, last visit: Dec 08, 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Moxifloxacin moxifloxacin 400 mg tablets once daily
Placebo identical appearing placebo

Participant Flow:   Overall Study
    Moxifloxacin     Placebo  
STARTED     34     32  
COMPLETED     34     31  
NOT COMPLETED     0     1  
Death                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Moxifloxacin moxifloxacin 400 mg tablets once daily
Placebo identical appearing placebo
Total Total of all reporting groups

Baseline Measures
    Moxifloxacin     Placebo     Total  
Number of Participants  
[units: participants]
  34     32     66  
Age  
[units: years]
Median ( Full Range )
  54  
  ( 21 to 68 )  
  50  
  ( 23 to 70 )  
  51.5  
  ( 21 to 70 )  
Gender  
[units: participants]
     
Female     14     11     25  
Male     20     21     41  
Height  
[units: cm]
Mean ± Standard Deviation
  172.71  ± 8.7     173.72  ± 9.7     173.2  ± 9.1  
Weight  
[units: kg]
Mean ± Standard Deviation
  76.41  ± 13.9     75.00  ± 16.5     75.73  ± 15.1  
Underlying Disease  
[units: 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  
[units: participants]
     
primary     20     14     34  
primary progressive     3     3     6  
relapsed     11     15     26  



  Outcome Measures
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1.  Primary:   Incidence of Clinically Significant Bacteremia   [ 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) ]

2.  Secondary:   Type of Isolates and Infections   [ 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) ]

3.  Secondary:   Time to Occurrence of Fever >= 38°C   [ 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) ]

4.  Secondary:   Reason for Discontinuation of Treatment   [ 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) ]

5.  Secondary:   Type of Infection   [ Time Frame: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation) ]

6.  Secondary:   Overall Survival   [ Time Frame: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof. Dr. Oliver A. Cornely
Organization: University of Cologne
phone: +49 221 478 88794
e-mail: oliver.cornely@zks-koeln.de


Publications of Results:

Responsible Party: Oliver Cornely, MD, University of Cologne
ClinicalTrials.gov Identifier: NCT00398411     History of Changes
Other Study ID Numbers: 05001, 2005-003271-21
Study First Received: November 8, 2006
Results First Received: August 5, 2013
Last Updated: October 16, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices