Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

This study has been completed.
Information provided by:
Johns Hopkins University Identifier:
First received: April 30, 2004
Last updated: March 26, 2013
Last verified: March 2013
Results First Received: March 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tuberculosis
Intervention: Drug: Moxifloxacin

  Participant Flow

  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.
125 had 8-week data (moxifloxacin n=64, ethambutol n=61)

Reporting Groups
Experimental Arm (Moxi) No text entered.
Control Arm (EMB) No text entered.
Total Total of all reporting groups

Baseline Measures
    Experimental Arm (Moxi)     Control Arm (EMB)     Total  
Number of Participants  
[units: participants]
  74     72     146  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     72     71     143  
>=65 years     2     1     3  
[units: years]
Mean (Standard Deviation)
  32.5  (11.7)     35.7  (12.0)     34.1  (11.9)  
[units: participants]
Female     34     22     56  
Male     40     50     90  
Region of Enrollment  
[units: participants]
Brazil     74     72     146  

  Outcome Measures
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1.  Primary:   Proportion of Patients With Sterile Sputum Cultures   [ Time Frame: 8 weeks ]

2.  Secondary:   Proportion of Patients With Grade 3 or 4 Adverse Reactions Attributable to Study Medications   [ Time Frame: 8 weeks ]

  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
No text entered.

  More Information
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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. Richard Chaisson
Organization: Johns Hopkins University
phone: 410-955-1755

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Dr. Richard E. Chaisson, Johns Hopkins University Identifier: NCT00082173     History of Changes
Other Study ID Numbers: FD-R-002135-01
Study First Received: April 30, 2004
Results First Received: March 26, 2013
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration