Table 2.
Changes in measured clinical variables from baseline to study completion
|
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 |
MUAC Mid Upper Arm Circumference; BMI Body Mass Index; 95 CI 95% Confidence Interval; SD Standard Deviation; s-25-(OH) D3 = serum 25-hydroxyvitamin D3.
1 Division of bilateral ling fields into a total of 6 zones (3 per each lung, ‘zone involvement’ = active parenchymal and cavitary disease, exclusive of old fibrotic scarring. 2 Includes all patients who were expectorating at baseline, and claimed ‘unable to expectorate’ at completion of treatment 12 weeks later. ESAT6 early secreted and T cell activated antigen-6 kDa; MTBs Mycobacterium tuberculosis whole sonicate antigen.
*Denotes cytokine levels after subtraction of background from unstimulated cells.