Table 2.
Primary treatment outcomes
| Treatment | ||||
| Outcome | ASAQ | AL |
Hazard ratio (95% CI) |
p valuea |
| Per protocolb | n = 96 | n = 103 | ||
| Recurrent parasitaemia | 15 (15.6%) | 23 (22.3%) | 1.49 (0.77–2.87) | 0.233 |
| Recurrent parasitaemia (PCR corrected) | 7 (7.3%) | 12 (11.7%) | 1.71 (0.67–4.38) | 0.265 |
| ETF | 0 | 0 | ||
| LCF | 7 (7.3%) | 18 (17.5%) | 2.41 (1.003–5.79) | 0.049 |
| LCF (PCR corrected) | 3 (3.1%) | 10 (9.7%) | 3.25 (0.89–11.92) | 0.075 |
| LPF | 8 (8.3%) | 5 (4.9%) | 0.64 (0.21–1.99) | 0.443 |
| LPF (PCR corrected) | 4 (4.2%) | 2 (1.9%) | 0.52 (0.09–2.87) | 0.452 |
| ACPR | 81 (84.4%) | 80 (77.7%) | 0.96 (0.70–1.31) | 0.792 |
| ACPR (PCR corrected) | 88 (91.7%) | 91 (88.3%) | 1 (0.74–1.34) | 0.986 |
| Intention to treatc | n = 108 | n = 109 | ||
| Recurrent parasitaemia | 15 (13.9%) | 23 (21.1%) | 1.51 (0.78–2.90) | 0.218 |
| Recurrent parasitaemia (PCR corrected) | 7 (6.5%) | 12 (11.0%) | 1.72 (0.67–4.41) | 0.256 |
| ETF | 0 | 0 | ||
| LCF | 7 (6.5%) | 18 (16.5%) | 2.44 (1.02–5.85) | 0.046 |
| LCF (PCR corrected) | 3 (2.8%) | 10 (9.2%) | 3.27 (0.89–11.96) | 0.073 |
| LPF | 8 (7.4%) | 5 (4.6%) | 0.66 (0.21–2.04) | 0.409 |
| LPF (PCR corrected) | 4 (3.7%) | 2 (1.8%) | 0.53 (0.10–2.94) | 0.468 |
| ACPR | 88 (81.5%) | 86 (78.9%) | 0.96 (0.71–1.30) | 0.813 |
| ACPR (PCR corrected) | 95 (88.0%) | 97 (89.0%) | 1.00 (0.75–1.33) | 0.988 |
Please note:
a Tested by Cox regression.
b Included were all patients who matched the inclusion criteria without violating the protocol.
c Included were all patients who matched all inclusion criteria without repeated vomiting after the first study drug administration.
CI, convidence interval; ASAQ, artesunate plus amodiaquine; AL, artemether-lumefantrine; ETF, early treatment failure; LCF, late clinical failure; LPF, late parasitological failure; ACPR, adequate clinical and parasitological response