Table 1.
Baseline characteristics of 1341 children enrolled in the efficacy study
| Variables | All treatments | P value | Artemether-lumefantrine | P value | Artesunate-amodiaquine | P value | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2009–2010 (n = 743) |
2014–2015 (n = 598) |
All (n = 1341) |
2009–2010 (n = 360) |
2014–2015 (n = 303) |
2009–2010 (n = 383) |
2014–2015 (n = 295) |
||||
| Male∶Female | 414∶329 | 312∶286 | 726∶615 | 0.22 | 201∶159 | 159∶144 | 0.43 | 213∶170 | 153∶142 | 0.39 |
| Age (month) | ||||||||||
| Mean | 36.3 | 39.8 | 37.8 | < 0.0001 | 36 | 40.5 | 0.001 | 36.5 | 39 | 0.04 |
| 95% CI | 35.1–37.4 | 38.4–41.1 | 37–38.7 | 34.2–37.8 | 38.6–42.3 | 35–38.1 | 37.2–40.9 | |||
| Number ≤ 24 months (%) | 237 (31.9) | 141 (23.6) | 378 (28.2) | 0.001 | 123 (34.2) | 68 (22.4) | 0.001 | 114 (29.8) | 73 (24.7) | 0.18 |
| Weight (kg) | ||||||||||
| Mean | 13.3 | 13.5 | 13.4 | 0.56 | 13.2 | 13.5 | 0.34 | 13.5 | 13.4 | 0.89 |
| 95% CI | 13–13.6 | 13.1–14 | 13.2–13.6 | 12.7–13.7 | 13–14 | 13.1–13.9 | 13–14 | |||
| Temperature (°C) | ||||||||||
| Mean | 38 | 37.8 | 37.9 | 0.005 | 38 | 37.9 | 0.12 | 38 | 37.8 | 0.02 |
| 95% CI | 37.9–38.1 | 37.7–37.9 | 37.9–38 | 37.9–38.1 | 37.8–38 | 37.9–38 | 37.6–37.9 | |||
| Number with | ||||||||||
| ≥ 37.5 °C (%) | 556 (74.8) | 377 (64) | 933 (69.6) | < 0.0001 | 267 (74.2) | 195 (64.4) | 0.008 | 289 (75.5) | 182 (64.4) | < 0.0001 |
| ≥ 40 °C (%) | 25 (3.4) | 53 (8.9) | 78 (5.8) | < 0.0001 | 13 (3.6) | 22 (7.3) | 0.06 | 12 (3.1) | 31 (7.3) | < 0.0001 |
| Haematocrit (%) | ||||||||||
| Mean | 29.8 | 30.4 | 30.1 | 0.04 | 29.7 | 30.3 | 0.11 | 29.9 | 30.5 | 0.17 |
| 95% CI | 29.4–30.2 | 30–30.8 | 29.8–30.4 | 29.1–30.2 | 30–30.8 | 29.4–30.5 | 29.9–31.1 | |||
| Number with anaemia (%) | 294 (39.6) | 233 (39) | 527 (39.3) | 0.15 | 142 (39.4) | 120(39.6) | 0.43 | 152 (39.7) | 113 (39.6) | 0.24 |
| (i) Mild (%) | 258 (34.7) | 216 (36.1) | 474 (35.3) | 0.64 | 124 (34.4) | 110 (36.3) | 0.68 | 134 (35) | 106 (36.3) | 0.84 |
| (ii) Moderate (%) | 34 (4.6) | 16 (2.7) | 50 (3.7) | 0.09 | 18 (5) | 10 (3.3) | 0.37 | 16 (4.2) | 6 (3.3) | 0.18 |
| (iii) Severe (%) | 2 (0.3) | 1 (0.2) | 3 (0.2) | 1.0 | 0 (0) | 0 (0) | – | 2 (0.5) | 1 (0) | 1.0 |
| Parasitaemia (μl−1) | ||||||||||
| Geometric mean | 14 733 | 15 887 | 15 237 | 0.4 | 15 169 | 16 250 | 0.65 | 14 337 | 15 519 | 0.48 |
| 95% CI | 13 108–16 239 | 14 211–17 760 | 14 050–16 403 | 12 993–17 710 | 13 938–18 | 12 201–16 413 | 13 200–18 244 | |||
| > 100 000 μl− 1 (%) | 71 (9.6) | 60 (10) | 131 (9.8) | 0.83 | 37 (10.3) | 956 30 (9.9) | 0.95 | 34 (8.9) | 30 (10.2) | 0.65 |
| Gametocytaemia (%) | 159 (21.4) | 29 (4.8) | 188 (14) | < 0.0001 | 82 (22.8) | 9 (3) | < 0.0001 | 77 (20.1) | 20 (6.8) | < 0.0001 |