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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398411
First Posted: November 10, 2006
Last Update Posted: June 29, 2015
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.
Information provided by (Responsible Party):
Oliver Cornely, MD, University of Cologne
Results First Submitted: August 5, 2013  
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

  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.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 ( 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