Criterion | Critical value for exclusion | Excluded n (%) |
Demographic | | |
Age years | >60 | 12 (2.9) |
| <18 | 8 (1.9) |
Incomplete or outdated records | Not allowed | 27 (6.4) |
Social | | |
Place of living | >100 km from site and no transport | 45 (10.7) |
Imprisonment or no fixed abode | Not allowed | 28 (6.7) |
Member of a gang/criminal organisation | Not allowed | 1 (0.2) |
Substance abuse | Not allowed | 19 (4.5) |
Alcohol abuse | Not allowed | 35 (8.3) |
Previous treatment default | Not allowed | 54 (12.8) |
Enrolled in other trial | Not allowed | 11 (2.6) |
Medical | | |
HIV-positive | | |
CD4 cell count mL–1 | <250 | 105 (24.9) |
Antiretroviral therapy | Not allowed | 108 (25.7) |
Karnofsky score | <50 | 44 (10.5) |
Insulin-dependent diabetes | Not allowed | 3 (0.7) |
Pregnant or breastfeeding | Not allowed | 2 (0.5) |
Uncontrolled epilepsy | Not allowed | 1 (0.2) |
Malabsorption | Not allowed | 1 (0.2) |
QT prolonging co-medication | Not allowed | 27 (6.4) |
Other critical co-medication | Not allowed | 14 (3.3) |
Tuberculosis | | |
Treatment initiated | Not allowed | 343 (81.5) |
<2 weeks | | 139 (33.0) |
<4 weeks | | 236 (56.1) |
Extrapulmonary TB | Not allowed | 4 (1.0) |
No resistance documented | Not allowed | 1 (0.2) |
Rifampicin monoresistance | Not allowed | 72 (17.1) |
Pre-XDR-TB | Not allowed | 26 (6.2) |
XDR-TB | Not allowed | 44 (10.5) |
MDR-TB treatment failure | Not allowed | 43 (10.2) |