| Intention-to-treat analysis | Modified ITT analysis | ||
---|---|---|---|---|
 | NTZ | Placebo | NTZ | Placebo |
Number of children | 30 | 30 | 26 | 26 |
Primary endpoints | Â | Â | Â | Â |
Proportion achieving well clinical response (number, %) | 14 (47) | 12 (40) | 11 (42) | 8 (31) |
Time to well clinical response(days) | 11.4 (7.2) | 7.9 (4.8) | 12.2 (9.6) | 13.8 (9.7) |
Secondary endpoints | Â | Â | Â | Â |
Parasitological eradication (number, %) | 10 (33) | 12 (40) | 7 (27) | 9 (35) |
Time to parasite eradication (days) | 8.7 (7.0) | 11.7 (9.0) | 8.0 (6.3) | 13.8 (9.5) |
Time to combined clinical and parasitological response | 19.1 (11.5) | 20.3 (10.1) | 12.7 (8.4) | 14.2 (7.8) |
Mortality (deaths by 4 weeks) | 11 (37) | 6 (20) | 10 (38) | 6 (23) |
Rate of reduction in stool frequency (expressed as change per day during treatment) (mean, SD) | -0.21 (0.34) | -0.16 (0.25) | - | - |
Nutritional response (change in weight over 4 weeks, kg) (mean, SD) | 0.8 (1.0) | 1.2 (0.9) | 1.3 (0.8) | 1.6 (0.8) |