At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of the Following: TMC207 Alone, TMC207 Plus Pyrazinamide,TMC207 Plus PA-824,PA-824 Plus Pyrazinamide and PA-824 Plus Pyrazinamide and Moxifloxacin, in Adult Patients With Newly Diagnosed, Smear-Positive Pulmonary Tuberculosis.
In Brief
A Phase 2 clinical trial evaluating PA-824, Pyrazinamide, and 3 other interventions for Pulmonary Tuberculosis. Completed, enrolled 85 participants across 2 sites.
Detailed Summary
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with pyrazinamide and PA-824 with moxifloxacin and pyrazinamide, as determined by the rate of change of log CFU in sputum over the time period Day 0-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.
Study Details
Timeline
Interventions
200 mg tablet, once daily for 14 days
Dosed by Weight
TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14
Rifafour e-275
moxifloxacin 400 mg