Conditions: Pulmonary Tuberculosis
Keywords: Bedaquiline Sirturo Early Bactericidal Activity EBA Pulmonary Tuberculosis TMC207
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 68
Healthy volunteers: no

Brief summary:
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 at multiple doses as determined by the rate of change of log10 colony forming units (CFU) per ml sputum over the time period Day 7-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.

Detailed description:

Arms:
arm 1: TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14 arm 2: TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14. arm 3: TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14 arm 4: TMC207- 200 mg Day 1 and 100 mg Days 2-14 arm 5: Rifafour e-275 mg

Interventions: intervention 1: TMC207 intervention 2: Rifafour e-275 mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: