Table 2. Microbiological results by study arm for both the ITT and per protocol analyses.
| Result | ITT Analysis | Per Protocol Analysis | ||||
| Xpert | Routine | p-Value | Xpert | Routine | p-Value | |
| N | 982 | 1,003 | 882 | 1,063 | ||
| Sputum available | 964 (98.2%) | 981 (97.8%) | 0.732 | 882 | 1,063 | |
| Xpert | ||||||
| Xpert available | 823 (85.4%) | 59 (6.0%) | 882 | |||
| Xpert negative | 619 | 47 | 666 | |||
| Xpert indeterminate | 5 | 0 | 5 | |||
| Xpert positive (percent of Xpert available) | 199 (24.2%) | 12 (20.3%) | 0.469 | 211 (23.9%) | ||
| Sputum smear microscopy | ||||||
| Smear available | 676 (68.8%) | 958 (95.5%) | 571 (64.7%) | 1,062 (99.9%) | ||
| Smear negative | 593 | 867 | 508 | 951 | ||
| Smear positive (percent of smear available) | 83 (12.3%) | 91 (9.5%) | 0.076 | 63 (11.0%) | 111 (10.5%) | 0.713 |
| Culture | ||||||
| Culture available | 474 (48.3%) | 459 (45.8%) | 0.476 | 418 (47.4%) | 515 (48.5%) | 0.493 |
| Contaminated/lost | 29 (6.1%) | 29 (6.3%) | 29 (6.8%) | 29 (5.6%) | ||
| Non-tuberculous mycobacteria | 8 | 2 | 7 | 3 | ||
| Culture negative | 318 | 319 | 281 | 356 | ||
| Culture positive (percent of valida culture results) | 119 (27.2%) | 109 (25.5%) | 0.533 | 101(26.4%) | 127 (26.3%) | 0.963 |
| Bacteriologically confirmed TB (Xpert, smear, or culture) | 257 (26.2%) | 167 (16.7%) | <0.001 | 235 (26.6%) | 189 (17.8%) | <0.001 |
Data are n (percent).
a
Excludes cultures that are contaminated.