Table 2.
Summary of analyses of time to culture conversion in MGIT culture (primary) and on solid LJ culture (secondary) to 12 weeks
| Control | RIF35HZE | RIFQHZ | RIF20QHZ | RIF20MHZ | Total | ||
|---|---|---|---|---|---|---|---|
| Total in analysis (mITT) | 123 | 63 | 58 | 56 | 63 | 363 | |
| Number of culture conversions during 26-week follow-up (MGIT culture) | 101 (82%) | 51 (81%) | 44 (76%) | 48 (86%) | 52 (83%) | 296 (82%) | |
| Number of culture conversions during 26-week follow-up (solid culture) | 117 (95%) | 59 (94%) | 59 (97%) | 54 (96%) | 59 (94%) | 345 (95%) | |
| Primary analysis to 12 weeks (MGIT culture) | |||||||
| Cumulative probability of culture conversion by 12 weeks | 70·1% | 79·9% | 65·2% | 58·6% | 78·7% | .. | |
| Median time to culture conversion (IQR) | 62 (41–83) | 48 (34–69) | 63 (48–83) | 66 (41–83) | 55 (41–69) | .. | |
| Adjusted hazard ratio (95%)* | .. | 1·78 (1·22–2·58) p=0·003 | 0·85 (0·57–1·27) p=0·42 | 0·76 (0·50–1·17) p=0·21 | 1·42 (0·98–2·05) p=0·07 | .. | |
| Hazard ratio (95%), unadjusted | .. | 1·46 (1·02–2·11) p=0·04 | 0·90 (0·60–1·34) p=0·60 | 0·76 (0·50–1·16) p=0·21 | 1·34 (0·93–1·93) p=0·12 | .. | |
| Solid LJ culture to 12 weeks (secondary) | |||||||
| Cumulative probability of culture conversion by 12 weeks | 97·3% | 100·0% | 94·4% | 94·2% | 98·0% | .. | |
| Median time to culture conversion (IQR) | 27 (13–48) | 20 (7–41) | 20 (7–48) | 20 (11–44) | 29 (20–48) | .. | |
| Adjusted hazard ratio (95% CI)* | .. | 1·23 (0·89–1·69) p=0·21 | 0·91 (0·66–1·27) p=0·58 | 0·98 (0·70–1·38) p=0·93 | 0·77 (0·56–1·06) p=0·11 | .. | |
| Unadjusted hazard ratio (95% CI) | .. | 1·28 (0·93–1·75) p=0·13 | 1·02 (0·73–1·41) p=0·92 | 1·06 (0·76–1·47) p=0·74 | 0·90 (0·65–1·23) p=0·50 | .. | |
LJ=Löwenstein-Jensen. MGIT=mycobacteria growth indicator tube. mITT=modified intention to treat. 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 400 mg. Doses of concomitant drugs are detailed in Procedures.
*
Analysis adjusted for HIV status, GeneXpert cycle threshold (<16, ≥16), and site. MGIT analyses also adjusted for baseline time to positivity.