Measured disease parameter(s) | Randomization | p-value (95% CI) | |
---|---|---|---|
Drug intervention (n = 132) | Placebo intervention (n = 127) | ||
TB Severity (clinical assessment) | |||
Mean Δ in TB score (points) ± SD, (95 CI) | - 3.19 ± 2.37, (−3.61, -2.75) | - 2.79 ± 2.44, (−3.23, -2.34) | 0.198 |
Mean Δ in weight (kg), (95% CI) | + 4.02, (3.18 – 4.86) | + 2.61, (1.99 – 3.23) | 0.007 |
Mean Δ in BMI, (95% CI) | + 1.48, (1.17 – 1.78) | + 0.96, (0.72 – 1.20) | 0.008 |
Mean Δ in MUAC (cm), (95% CI) | + 1.34, (0.74 – 1.64) | + 0.97, (0.68 – 1.26) | 0.079 |
Chest X-Ray Involvement | |||
Mean no. of zones1 involved ± SD | 1.35 ± 1.13 | 1.82 ± 1.35 | 0.004 |
Sputum Smear | |||
Smear Conversion, no. (%) 2 | 108 (81.8) | 103 (81.1) | 0.39 |
IFN-g levels (pg/ml) mean ± SD | |||
Unstimulated levels | 3.9 ±28.7 | 4.3 ± 45.2 | 0.325 |
ESAT6-stimulated* | 387 ±920 | 206 ±665 | 0.077 |
MTBs-stimulated* | 3092 ±1363 | 2987 ±1510 | 0.497 |