Table 2.
Per-protocol crude/unadjusted and PCR-adjusted study endpoints at days 28 and 42 of patient follow-up. Patients with re-infections and individuals for whom the outcome could not be assessed by PCR were censored from the PCR adjusted analysis
| Crude/no PCR | Day 28 | Day 42 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ASAQ (n = 119) | AL (n = 122) | p value | ASAQ (n = 119) | AL (n = 119) | p value | |||||
| n | % | n | % | n | % | n | % | |||
| Late clinical failure | 8 | 6.7 | 4 | 3.3 | 0.250 | 13 | 10.9 | 10 | 8.4 | 0.510 |
| Late parasitological failure | 10 | 8.4 | 6 | 4.9 | 0.277 | 14 | 11.8 | 9 | 7.6 | 0.273 |
| Adequate clinical and parasitological response | 101 | 84.9 | 112 | 91.8 | 0.093 | 92 | 77.3 | 100 | 84.0 | 0.189 |
| Cumulative failure | 18 | 15.1 | 10 | 8.2 | 0.093 | 27 | 22.7 | 19 | 16.0 | 0.189 |
| PCR adjusted/corrected | Day 28 | Day 42 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ASAQ (n = 105) | AL (n = 111) | p value | ASAQ (n = 98) | AL (n = 101) | p value | |||||
| n | % | n | % | n | % | n | % | |||
| Late clinical failure (recrudescence) | 1 | 1.0 | 0 | 0 | 0.486 | 1 | 1.0 | 1 | 1.0 | 1.000 |
| Late parasitological failure (recrudenscence) | 3 | 2.9 | 0 | 0 | 0.113 | 5 | 5.1 | 0 | 0 | 0.027 |
| Adequate clinical and parasitological response | 101 | 96.2 | 111 | 100 | 0.038 | 92 | 93.9 | 100 | 99.0 | 0.049 |
| Cumulative failure | 4 | 3.8 | 0 | 0 | 0.054 | 6 | 6.1 | 1 | 1.0 | 0.062 |
The analysis of the treatment outcomes by intention-to-treat are shown in Additional file 1: Annexure 1