Cohort Name | NexGen EBA Cohorta | Biobank Sputum Specimen Cohort | Kawasaki Study Cohortsb | |
---|---|---|---|---|
Cohort Type | Treatment Clinical study NCT02371681a | Diagnostic In vitro study using biobanked sputum samples | Diagnostic | Treatment |
Participants (n) | 178 | 250 | 308 | 40 |
Cohort Population | Adults with smear (+) pulmonary TB undergoing treatment for drug-susceptible TB | Adults suspected of pulmonary TB prior to treatment, and adult participants without TB | Adults suspected of pulmonary TB prior to treatment, and adult participants without TB | Adults with smear (+) pulmonary TB undergoing treatment for drug-susceptible TB |
Treatment Regimen(s) (n) | Arm 1: Isoniazid (H) (22) Arm 2: Rifampin (R) (22) Arm 3: Pyrazinamide (Z) (22) Arm 4: Moxifloxacin (M) (23) Arm 5: R + Z (23) Arm 6: H + Z (22) Arm 7: MRZE (22) Arm 8: HRZE (22) | Diagnostic (250) | Diagnostic (308) | Standard of care regimen: Isoniazid (H), Rifampin (R), Pyrazinamide (Z), and Ethambutol (E): HRZE (40) |
Duration (days) | 14 | Pre-treatment only | Pre-treatment only | 56 |
Pharmacodynamic Response Measures (N) | 1. AFB smear grade (Screening only) 2. CFU concentration (2323) 3. LAM concentration direct (439) and sediment (445) 4. MGIT-TTD (2459) 5. Xpert Cycle Threshold (Screening only) | 1. AFB smear grade 2. Culture positivity (LJ media and MGIT [binary status]) 3. LAM concentration direct (250) | 1. AFB smear grade 2. Culture positivity (LJ media and MGIT [binary status]) 3. LAM concentration direct (308) and sediment (308) 4. MGIT-TTD (271) 5. Xpert Cycle Threshold | 1. AFB smear grade 2. LAM concentration direct (202) and sediment (175) 3. MGIT-TTD (180) |
Sampling Daysc | Screening, Baseline, Day 7, and Day 13 | Baseline (pre-treatment) | Baseline (pre-treatment) | Baseline, Day 3, Day 7, Day 14, Day 28, and Day 56 |