Table 3.
Efficacy Assessments at Day 28 and Day 42 for the Intention-to-Treat Population
| Variables | Artesunate– Amodiaquine, n = 189 (%) | Chloroquine, n = 190 (%) | Difference (95% Confidence Interval) | P value |
|---|---|---|---|---|
| Day 28 | ||||
| Genotype-adjusted ACPR | 177 (93.7) | 172 (90.5) | 3.1% (−2⋅3–8⋅5) | .345 |
| Total failures | 12 (6.3) | 18 (9.5) | ||
| Late clinical failure | 0 (0.0) | 4 (2.1) | ||
| Late parasitological failure | 0 (0.0) | 7 (3.7) | ||
| Missing data a | 12 (6.3) | 7 (3.7) | ||
| Genotype classification of failures | ||||
| Homologous | 0 | 10 (5.8) | ||
| Heterologous | 0 | 2 (1.2) | ||
| Indeterminate | 0 | 1 (0.6) | ||
| Unadjusted ACPR | 177 (93.7) | 170 (89.5) | 4.2% (−1.4–9.8) | .201 |
| Total failuresa | 12 (6.3) | 20 (10.5) | ||
| Late clinical failure | 0 | 4 (2.1) | ||
| Late parasitological failure | 0 | 9 (4.7) | ||
| Day 42 | ||||
| Genotype-adjusted ACPR | 162 (85.7) | 136 (71.6) | 14.1% (6.0–22.3) | .001 |
| Total failures | 27 (14.3) | 54 (28.4) | ||
| Late clinical failure | 2 (1.1) | 15 (7.9) | ||
| Late parasitological failure | 2 (1.1) | 26 (13.7) | ||
| Missing data a | 23 (12.2) | 13 (6.8) | ||
| Genotype classification of failures | ||||
| Homologous | 3 (1.6) | 34 (18.4) | ||
| Heterologous | 2 (1.1) | 7 (3.7) | ||
| Indeterminate polymerase chain reaction | 1 (0.5) | 7 (3.7) | ||
| Unadjusted ACPR | 160 (84.7) | 129 (67.9) | 16.8% (8.4–25.2) | <.001 |
| Total failures | 29 (15.5) | 61 (32.1) | ||
| Late clinical failure | 2 (1.1) | 18 (9.5) | ||
| Late parasitological failure | 4 (2.1) | 30 (15.8) | ||
| Parasite and fever clearance | ||||
| Parasite cleared at day 1 | 38 (20.1) | 9 (4.7) | <.001 | |
| Parasite cleared at day 2 | 162 (85.7) | 89 (46.8) | <.001 | |
| Parasite cleared at day 3 | 184 (97.4) | 153 (80.5) | <.001 | |
| Fever cleared at day 1 | 184 (97.4) | 168 (88.4) | <.001 | |
Genotyping detailed data available in Supplementary Table S1.
Abbreviation: ACPR, adequate cure and parasitological response.
aLosses to follow-up and samples with genotype assessment..