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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
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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
Subjects with respiratory symptoms suggestive of TB were recruited from the HUCFF outpatient TB clinic as well as other local TB clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who did not meet enrollment criteria or who did not want to participate in the study were excluded.

Reporting Groups
  Description
Experimental Arm INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
Control Arm INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks

Participant Flow:   Overall Study
    Experimental Arm     Control Arm  
STARTED     74     72  
COMPLETED     64     61  
NOT COMPLETED     10     11  
Withdrawal by Subject                 3                 5  
Lost to Follow-up                 1                 0  
Adverse Event                 1                 0  
Culture negative or resistant at baselin                 5                 6  



  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
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Time Frame 18 months
Additional Description No text entered.

Reporting Groups
  Description
Experimental Arm INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
Control Arm INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks

Serious Adverse Events
    Experimental Arm     Control Arm  
Total, serious adverse events      
# participants affected / at risk     6/74 (8.11%)     6/72 (8.33%)  
Cardiac disorders      
Death † 1 [3]    
# participants affected / at risk     3/74 (4.05%)     5/72 (6.94%)  
# events     3     5  
General disorders      
Hospitalization † 1 [4]    
# participants affected / at risk     3/74 (4.05%)     3/72 (4.17%)  
# events     4     3  
Renal and urinary disorders      
Grade 4 event † 1 [5]    
# participants affected / at risk     1/74 (1.35%)     0/72 (0.00%)  
# events     1     0  
Events were collected by systematic assessment
1 Term from vocabulary, DAIDS Toxicity Table
[3] Causes of deaths in the study included: sepsis, gunshots, neoplasm, intracranial hemorrhage, PTB and unknown, none related to study medications
[4] Hospitalization AEs for this study included:Community acquired pneumonia, abscess, D&C, edema and polyneuropathy, none related to study drugs
[5] Proteinuria, judged to be not related to study drugs




  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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