Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00082173
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
  Description
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  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     72     71     143  
>=65 years     2     1     3  
Age  
[units: years]
Mean ± Standard Deviation
  32.5  ± 11.7     35.7  ± 12.0     34.1  ± 11.9  
Gender  
[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.


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