Treatment outcome | Artemether–lumefantrine | Pyronaridine–artesunate | Total | ρ-value |
---|---|---|---|---|
N (%) | N (%) | N (%) | ||
TOTAL enrolled | 87 (100) | 85 (100) | 172 (100) | |
Completed study | 83 (95.4) | 82 (96.5) | 165 (95.9) | 0.535 |
LTFU | 3 (3.4) | 2 (2.4) | 5 (2.9) | |
Withdrawn | 1 (1.2) | 0 (0.0) | 1 (0.6) | |
Withdrawal of consent | 0 (0.0) | 1 (1.2) | 1 (0.6) | |
ITT-uncorrected | N = 87 (100) | N = 85 (100) | N = 172 (100) | |
ACPR—D28 | 59 (67.8) | 76 (89.4) | 135 (78.5) | 0.001 |
Treatment failure | 24 (27.6) | 6 (7.1) | 30 (17.4) | |
LTFU/withdrawn | 4 (4.6) | 3 (3.5) | 7 (4.1) | |
PP—uncorrected | N = 83 | N = 82 | N = 165 | |
ACPR—D21 | 73/83 (88.0) | 82/83 (98.8) | 135/166 (93.4) | 0.016 |
ACPR—D28 | 59/83 (71.1) | 76/82 (92.7) | 135/165 (81.8) | |
LPF—D28 | 17 (20.5) | 6 (7.3) | 23 (13.9) | 0.001 |
LCF—D28 | 7 (8.4) | 0 (0.0) | 7 (4.2) | |
PP-PCR corrected | N = 67 | N = 78 | N = 145 | |
Cure rate—D28 | 59 (88.1) | 76 (97.4) | 135 (93.1 | 0.04 |
Recrudescence | 8 (11.9) | 2 (2.6) | 9 (6.9) | |
Day of failure [N (%)] | 24 (110) | 6 (100) | 30 (100) | |
Day 14 | 2 (8.3) | 0 (0.0) | 2 (6.7) | |
Day 21 | 9 (37.5) | 1 (16.7) | 10 (33.3) | 0.405 |
Day 28 | 13 (54.2) | 5 (83.3) | 18 (60.0) | |
% Failed before D28 | 11 (45.8) | 1 (16.7) | 12 (40.0) | |
% Failed on D28 | 13 (54.2) | 5 (83.3) | 18 (60.0) | 0.358 |
Parasite clearance time (days) | ||||
Mean ± SD | 2.15 ± 0.68 | 2.08 ± 0.64 | 2.12 ± 0.66 | 0.430 |
Range | 1–4 | 1–3 | 1–4 | |
Fever clearance time (days) | ||||
Mean ± SD | 1.11 ± 0.32 | 1.13 ± 0.44 | 1.13 ± 0.38 | 0.664 |
Range | 1–2 | 1–3 | 1–3 | |
Haematocrit at D28 (in %) | ||||
Mean ± SD | 33.3 ± 2.95 | 34.9 ± 2.79 | 34.13 ± 2.95 | 0.002 |
Range | 23–40 | 28–42 | 25–42 | |
Haematocrit < 30% D28 | 1 (1.4) | 1 (1.4) | 2 (1.4) | 1.000 |