Table 2. Proportions of participants with negative cultures at completion of intensive phase treatment.
Culture Medium for Endpoint Assessment | Investigational Arm PMHZ | Control Arm REHZ | Difference in % (95% CI) | P value |
---|---|---|---|---|
Modified intention-to-treat analysis population: missing week 8 result classified as culture positive | ||||
Löwenstein-Jensen solid culture | 47/60 (78.3%) | 43/51 (84.3%) | -6.0 (-19.9, 10.3) | 0.47 |
MGIT liquid culture | 37/47 (78.7%) | 27/41 (65.9%) | 12.9 (-7.8, 31.7) | 0.23 |
Modified intention-to-treat analysis population: if week 8 result missing, then last result carried forward | ||||
Löwenstein-Jensen solid culture | 53/60 (88.3%) | 46/51 (90.2%) | -1.9 (-12.6, 10.7) | 1.00 |
MGIT liquid culture | 40/47 (85.1%) | 29/41 (70.7%) | 14.4 (-5.0, 30.5) | 0.12 |
Per-protocol analysis population | ||||
Löwenstein-Jensen solid culture | 46/49 (93.9%) | 41/45 (91.1%) | 2.8(-8.1, 12.0) | 0.71 |
MGIT liquid culture | 36/38 (94.7%) | 26/36 (72.2%) | 22.5(3.0, 31.4) | 0.01 |