Conditions: Pulmonary Tuberculosis
Keywords: Tuberculosis Serial Sputum Colony Counts Colony Forming Units Time to Sputum Culture Positivity PA824 pretomanid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 207
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus PA-824 plus pyrazinamide regimen after 8 weeks of treatment.

Detailed description:

Arms:
arm 1: Drug Sensitive Participants: One moxifloxacin (M) 400 mg tablet plus one Pretomanid (PA-824) 100 mg tablet plus three pyrazinamide 500 mg tablets taken once daily for 8 weeks arm 2: Drug Sensitive Participants: One moxifloxacin (M) 400 mg tablet plus one Pretomanid (PA-824) 200 mg tablet plus three pyrazinamide 500 mg tablets taken once daily for 8 weeks arm 3: Drug Sensitive Participants: Rifafour was administered orally once daily for 8 weeks according to weight: 30 kg to 37 kg: two tablets; 38 kg to 54 kg: three tablets; 55 kg to 70 kg: four tablets; ≥71 kg: five tablets arm 4: Multi Drug-Resistant Participants: One moxifloxacin (M) 400 mg tablet plus one Pretomanid (PA-824) 200 mg tablet plus three pyrazinamide 500 mg tablets taken once daily for 8 weeks

Interventions: intervention 1: Moxifloxacin (M) intervention 2: Pretomid (Pa) intervention 3: Pyrazinamide (Z) intervention 4: Rifafour
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: 2 tablets, 38-54 kg: 3 tablets, 55-70 kg: 4 tablets: 71 kg and over: 5 tablets

Protocol document: