Table 1.
Demographic and clinical characteristics of the study population.
| No. patients |
Number with stable sputum conversion on solid and liquid media |
|||
|---|---|---|---|---|
| (% of total) | (% of category) | |||
| Characteristic | At 8 weeks | At 12 weeks | At 16 weeks | |
| All subjects | 319 (100%) | 209 (66%) | 264 (83%) | 316 (99.1%) |
| Gender | ||||
| Female | 107 (34%) | 86 (80%) | 93 (87%) | 105 (98.1%) |
| Male | 212 (66%) | 123 (58%) | 171 (81%) | 211 (99.5%) |
| Age | ||||
| 0–20 | 17 (5%) | 13 (76%) | 16 (94%) | 17 (100.0%) |
| 21–40 | 203 (64%) | 128 (63%) | 169 (83%) | 203 (100.0%) |
| 41–60 | 80 (25%) | 54 (68%) | 63 (79%) | 78 (97.5%) |
| 61 | 19 (6%) | 14 (74%) | 16 (84%) | 18 (94.7%) |
| Body mass index | ||||
| BMI ≤ 18.5 | 97 (30%) | 56 (58%) | 80 (82%) | 95 (97.9%) |
| BMI > 18.5 | 222 (70%) | 153 (69%) | 184 (83%) | 221 (99.5%) |
| Location | ||||
| N. America | 109 (34%) | 85 (78%) | 99 (91%) | 107 (98.2%) |
| Spain | 24 (8%) | 17 (71%) | 19 (79%) | 24 (100.0%) |
| S. Africa | 64 (20%) | 44 (69%) | 54 (84%) | 64 (100.0%) |
| Uganda | 122 (38%) | 63 (52%) | 92 (75%) | 121 (99.2%) |
| HIV status | ||||
| Negative | 284 (89%) | 189 (67%) | 235 (83%) | 282 (99.3%) |
| Positive | 35 (11%) | 20 (57%) | 29 (83%) | 34 (97.1%) |
| Baseline smear | ||||
| Low | 114 (36%) | 91 (80%) | 102 (89%) | 114 (100.0%) |
| High | 205 (64%) | 118 (58%) | 162 (79%) | 202 (98.5%) |
| Baseline chest x-Ray | ||||
| No cavity | 115 (36%) | 84 (73%) | 98 (85%) | 115 (100.0%) |
| Cavity ≤ 4 cm | 80 (25%) | 54 (68%) | 70 (88%) | 79 (98.8%) |
| Cavity > 4 cm | 124 (39%) | 71 (57%) | 96 (77%) | 122 (98.4%) |
| Baseline MGIT960 | ||||
| TTD < = 5 days | 82 (26%) | 45 (55%) | 64 (78%) | 79 (96.3%) |
| TTD > 5 days | 237 (74%) | 164 (69%) | 200 (84%) | 237 (100.0%) |
| Study arm | ||||
| Rifampin | 151 (47%) | 93 (62%) | 124 (82%) | 151 (100.0%) |
| Rifapentine | 168 (53%) | 116 (69%) | 140 (83%) | 165 (98.2%) |
MGIT960 TTD refers to the time-to-detection for baseline liquid mycobacterium growth indicator tube system (MGIT) 960 cultures. Sputum conversion indicates negative sputum culture on both solid and liquid media at the specified time point.