Endpoint (treatment outcome) | Control arm | Intervention arm |
---|---|---|
Early treatment failure, n (%) | 0 | 0 |
Late clinical failure before D7, n (%) | 0 | 0 |
Late clinical failure, on or after D7 n/N (%) | 14/121 (11.6) | 6/121 (5.0) |
 Due to recrudescence | 1 | 0 |
 Due to reinfection | 11 | 3 |
 Undetermined or missing PCR data n/N | 2 | 3 |
Late parasitological failure, n/N (%) | 7/121 (5.8) | 8/121 (6.6) |
 Due to recrudescence | 2 | 2 |
 Due to reinfection | 2 | 5 |
 Undetermined or missing PCR data | 3 | 1 |
Adequate clinical and parasitological response by D28, n/N (%) | 115/121 (95.0) | 118/121 (97.5) |
Adequate clinical and parasitological response by D42, n/N (%) | 100/103 (97.1) | 107/109 (98.2) |
No treatment outcome | ||
 Lost to follow-up total, n/N (%) | 17/141 (12.1) | 17/139 (12.2) |
 Withdrew consent or protocol violation n/N (%) | 3/141 (1.4) | 1/139 (0.7) |