Conditions: Pulmonary Tuberculosis
Keywords: Early Bactericidal Activity EBA pulmonary tuberculosis PA-824 Pretomanid CL-007
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 69
Healthy volunteers: no

Brief summary:
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard TB treatment.

Detailed description:

Arms:
arm 1: PA-824 200 mg/qd arm 2: PA-824 600 mg/qd arm 3: PA-824 1000 mg/qd arm 4: PA-824 1200 mg/qd arm 5: Rifafour e-275 mg

Interventions: intervention 1: PA-824
Intervention descriptions: intervention 1: 200 mg, 600 mg, 100 mg, 1200 mg qd

Protocol document: