Conditions: Pulmonary Tuberculosis
Keywords: Early Bactericidal Activity EBA Pulmonary Tuberculosis PA-824 pretomanid
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 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive standard TB treatment.

Detailed description:
The planned sample size of 15 participants per treatment group is in keeping with other Phase II trials of this type and accounts for the possibility of up to 3 drop-outs per arm, which based on previous studies of this type conducted at these sites, represents a conservative estimate of the expected drop-out rate.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: PA-824 intervention 2: PA-824 intervention 3: PA-824 intervention 4: Rifafour e-275 mg intervention 5: PA-824
Intervention descriptions: intervention 1: 50mg intervention 2: 100mg intervention 3: 150 mg intervention 4: 275 mg intervention 5: 200 mg

Protocol document: