Outcome: day 42 | AL | ASAQ | Difference (CI 95%) | p-value |
---|---|---|---|---|
Variables | ||||
PCR corrected efficacy outcome—no. (%) | ||||
Per protocol population (N = 420) n (%) | 213 | 207 | – | – |
Adequate clinical and parasitological response | 194 (91.1) | 203 (98.1) | − 7 (− 11.0 to − 2.7) | < 0.0006 |
Early treatment failure | 0 (0.0) | 0 (0) | – | – |
Late clinical failure | 0 (0.0) | 0 (0) | – | – |
Late parasitological failure | 19 (8.9) | 4 (1.9) | – | – |
Total number of failure | 19 (8.9) | 4 (1.9) | – | – |
Not corrected for reinfection n (%) | ||||
Adequate clinical and parasitological response | 106 (49.8) | 147 (71.0) | − 22 (− 31.1 to − 12.9) | < 0.0001 |
Early treatment failure | 0 (0) | 0 (0) | – | – |
Late clinical failure | 32 (15.0) | 22 (10.6) | – | – |
Late parasitological failure | 75 (35.2) | 38 (18.4) | – | – |
Total number of failure | 107 (50.2) | 60 (28.9) | – | – |
Intent-to-treat population (N = 440) | 220 | 220 | – | – |
PCR-adjusted | ||||
Total number of patients n | 194 | 203 | ||
Adequate clinical and parasitological response % (95% CI) | 88.2 (83.2–91.8 | 92.3 (87.9–95.2) | − 4.1 (− 9.8 to − 1.5) | 0.148 |
PCR-unadjusted | ||||
Total number of patients n | 106 | 147 | – | – |
Adequate clinical and parasitological response % (95% CI) | 48.2 (41.6–54.8) | 66.8 (60.3–72.8) | − 18.6 (− 27.4 to 9.4) | < 0.001 |