Table 2.
Baseline characteristics (mITT population)
| DS-TB | RR-TB | |||||
|---|---|---|---|---|---|---|
| Total* (n = 234) n (%) | HRZE (n = 60) n (%) | 4Pa100MZ† (n = 57) n (%) | 4Pa200MZ† (n = 61) n (%) | 6Pa200MZ† (n = 56) n (%) | 6Pa200MZ† (n = 11) n (%) | |
| Male sex | 167 (71.4) | 42 (70.0) | 46 (80.7) | 42 (68.9) | 37 (66.1) | 5 (45.5) |
| Age, years, median (min–max) | 34.0 (18.0–77.0) | 32.5 (19.0–69.0) | 37.0 (18.0–60.0) | 37.0 (18.0–77.0) | 31.0 (18.0–64.0) | 28.0 (20.0–43.0) |
| Weight, kg, median (min–max) | 53.0 (32.2–137.8) | 54.9 (34.0–107.5) | 51.3 (37.0–137.8) | 53.0 (35.6–81.4) | 52.6 (32.2–82.0) | 55.7 (43.1–74.0) |
| Black | 164 (70.1) | 41 (68.3) | 41 (71.9) | 43 (70.5) | 39 (69.6) | 8 (72.7) |
| Smoking history | ||||||
| Never | 81 (34.6) | 16 (26.7) | 23 (40.4) | 20 (32.8) | 22 (39.3) | 6 (54.5) |
| Past | 41 (17.5) | 14 (23.3) | 7 (12.3) | 14 (23.0) | 6 (10.7) | 2 (18.1) |
| Current | 107 (45.7) | 29 (48.3) | 24 (42.1) | 27 (44.3) | 27 (48.2) | 3 (27.3) |
| Missing | 5 (2.1) | 1 (1.7) | 3 (5.3) | 0 (0.0) | 1 (1.8) | 0 (0.0) |
| HIV-positive | 58 (24.8) | 15 (25.0) | 13 (22.8) | 13 (21.3) | 17 (30.4) | 6 (54.5) |
| Resistant to INH | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (45.4) |
| CXR cavitation present | 170 (72.6) | 41 (68.3) | 40 (70.2) | 43 (70.5) | 46 (82.1) | 10 (90.9) |
| Baseline TTP ≥ median | 125 (53.4) | 28 (46.7) | 28 (49.1) | 34 (55.7) | 35 (62.5) | 11 (100.0) |
* Includes control arm but does not include the (non-randomised) RR-TB patients.
† 200 mg pretomanid (Pa, PMD) daily, 400 mg moxifloxacin (M) and 1500 mg pyrazinamide (Z) for 6 months (6Pa200MZ) or 4 months (4Pa200MZ); 100 mg pretomanid daily for 4 months in the same combination (4Pa100MZ).
mITT = modified intention-to-treat; DS-TB = drug-susceptible TB; RR-TB = rifampicin-resistant TB; H, INH = isoniazid; R = rifampicin; Z = pyrazinamide; E = ethambutol; M = moxifloxacin; Pa = pretomanid; CXR = chest X-ray; TTP = time to positive result (in liquid culture).