Outcome | Pyronaridine-artesunate | Artemether-lumefantrine | Difference (95% CI); |
---|---|---|---|
P valuea | |||
Day-28 PCR-corrected ACPR,b n/N | 333/355 | 167/180 | |
% (95% CI) | 93.8 (90.8–96.1) | 92.8 (88.0–96.1) | 1.0 (–3.2 to 6.2); P = .65 |
P value (exact binomial test)c | 0.0077 | NC | |
Total failures | 22 (6.2) | 13 (7.2) | |
Early treatment failure | 2 (0.6) | 0 | |
Late clinical failure | 2 (0.6) | 0 | |
Late parasitological failure | 6 (1.7) | 2 (1.1) | |
Missing = failure | 10 (2.8) | 6 (3.3) | |
Re-infection before day 28 | 2 (0.6) | 5 (2.8) | |
Day-28 crude ACPR, n/N | 308/355 | 151/180 | |
% (95% CI) | 86.8 (82.8–90.1) | 83.9 (77.7–88.9) | 2.9 (–3.2 to 9.7); P = .37 |
Total failures | 47 (13.2) | 29 (16.1) | |
Early treatment failure | 2 (0.6) | 0 | |
Late clinical failure | 6 (1.7) | 4 (2.2) | |
Late parasitological failure | 29 (8.2) | 19 (10.6) | |
Missing = failure | 10 (2.8) | 6 (3.3) | |
Day-42 PCR-corrected ACPR,b n/N | 271/355 | 140/180 | |
% (95% CI) | 76.3 (71.6–80.7) | 77.8 (71.0–83.6) | –1.4 (–8.6 to 6.4); P = .71 |
Total failures | 84 (23.7) | 40 (22.2) | |
Early treatment failure | 2 (0.6) | 0 | |
Late clinical failure | 2 (0.6) | 0 | |
Late parasitological failure | 15 (4.2) | 6 (3.3) | |
Missing = failure | 12 (3.4) | 6 (3.3) | |
Re-infection before day 42 | 53 (14.9) | 28 (15.6) | |
Day-42 crude ACPR, n/N | 264/355 | 136/180 | |
% (95% CI) | 74.4 (69.5–78.8) | 75.6 (68.6–81.6) | –1.2 (–8.6 to 6.8); P = .77 |
Total failures | 91 (25.6) | 44 (24.4) | |
Early treatment failure | 2 (0.6) | 0 | |
Late clinical failure | 14 (3.9) | 5 (2.8) | |
Late parasitological failure | 63 (17.7) | 33 (18.3) | |
Missing = failure | 12 (3.4) | 6 (3.3) |