Table 1.
Baseline characteristics by arm
| Control | RIF35HZE | RIFQHZ | RIF20QHZ | RIF20MHZ | Total | ||
|---|---|---|---|---|---|---|---|
| Number randomised* | 123 | 63 | 59 | 57 | 63 | 365 | |
| Age (years) | 34 (26–41) | 33 (23–40) | 32 (25–40) | 34 (27–41) | 31 (24–38) | 33 (26–40) | |
| Male | 94 (76%) | 42 (67%) | 38 (64%) | 45 (79%) | 39 (62%) | 258 (71%) | |
| Weight (Kg) | 54 (49–59) | 52 (47–58) | 53 (47–57) | 53 (49–56) | 52 (48–61) | 53 (49–58) | |
| HIV positive | 9 (7%) | 4 (6%) | 5 (8%) | 3 (5%) | 3 (5%) | 24 (7%) | |
| Ethnicity | |||||||
| Black | 101 (82%) | 51 (81%) | 50 (85%) | 50 (88%) | 48 (76%) | 300 (82%) | |
| White | 0 (0%) | 1 (2%) | 0 (0%) | 1 (2%) | 0 (0%) | 2 (1%) | |
| Mixed | 19 (15%) | 11 (17%) | 9 (15%) | 6 (11%) | 15 (24%) | 60 (16%) | |
| Other | 3 (2%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (1%) | |
| Xpert MTB/RIF cycle threshold | 16 (14–19) | 17 (14–20) | 17 (14–19) | 16 (14–18) | 16 (14–19) | 16 (14–19) | |
| Phenotypic resistance to rifampicin | |||||||
| Resistant | 0 (0%) | 0 (0%) | 1 (2%) | 1 (2%) | 0 (0%) | 2 (1%) | |
| Sensitive | 112 (91%) | 59 (94%) | 54 (92%) | 53 (93%) | 56 (89%) | 334 (92%) | |
| Missing | 11 (9%) | 4 (6%) | 4 (7%) | 3 (5%) | 7 (11%) | 29 (8%) | |
| Phenotypic resistance to isoniazid | |||||||
| Resistant | 3 (2%) | 0 (0%) | 3 (5%) | 1 (2%) | 1 (2%) | 8 (2%) | |
| Sensitive | 109 (89%) | 59 (94%) | 52 (88%) | 53 (93%) | 55 (87%) | 328 (90%) | |
| Missing | 11 (9%) | 4 (6%) | 4 (7%) | 3 (5%) | 7 (11%) | 29 (8%) | |
| Phenotypic resistance to moxifloxacin | |||||||
| Resistant | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| Sensitive | 115 (93%) | 59 (94%) | 55 (93%) | 54 (95%) | 56 (89%) | 339 (93%) | |
| Missing | 8 (7%) | 4 (6%) | 4 (7%) | 3 (5%) | 7 (11%) | 26 (7%) | |
| Phenotypic resistance to ethambutol | |||||||
| Resistant | 0 (0%) | 0 (0%) | 0 (0%) | 1 (2%) | 0 (0%) | 1 (0%) | |
| Sensitive | 112 (91%) | 59 (94%) | 55 (93%) | 53 (93%) | 56 (89%) | 335 (92%) | |
| Missing | 11 (9%) | 4 (6%) | 4 (7%) | 3 (5%) | 7 (11%) | 29 (8%) | |
| Phenotypic resistance to pyrazinamide | |||||||
| Resistant | 4 (3%) | 2 (3%) | 2 (3%) | 0 (0%) | 4 (6%) | 12 (3%) | |
| Sensitive | 110 (89%) | 57 (90%) | 53 (90%) | 55 (96%) | 53 (84%) | 328 (90%) | |
| Missing | 9 (7%) | 4 (6%) | 4 (7%) | 2 (4%) | 6 (10%) | 25 (7%) | |
*
An additional three patients were randomised in error and did not start treatment or remain in follow-up and are therefore not included in this table. RIF35HZE=rifampicin 35 mg/kg, isoniazid, pyrazinamide, ethambutol. RIFQHZ =rifampicin 10 mg/kg, isoniazid, pyrazinamide, SQ109 300 mg. RIF20QHZ=rifampicin 20 mg/kg, isoniazid, pyrazinamide, SQ109 300 mg. RIF20MHZ=rifampicin 20 mg/kg, isoniazid, pyrazinamide, moxifloxacin 400mg. Data are median (IQR) or n (%) unless otherwise specified. Doses of concomitant drugs are detailed in Procedures.