Table 1.
General characteristics of study population at enrolment according to study arms
| Parameters | Pyronaridine-artesunate (PA), N = 224 |
Artemether–lumefantrine (AL), N = 296 |
|---|---|---|
| Sex (male), n (%) | 95 (42.41) | 133 (44.93) |
| Age, mean ± SD (in year) | 8.96 ± 6.52 | 9.29 ± 7.56 |
| Age groups (in year), n (%) | ||
| ≤ 5 | 58 (25.9) | 84 (28.38) |
| > 5 to ≤ 15 | 138 (61.61) | 171 (57.77) |
| > 15 | 28 (12.5) | 41 (13.85) |
| Weight, mean ± SD | 25.99 ± 14.46 | 26.33 ± 14.70 |
| Height, mean ± SD | 124.47 ± 24.86 | 124.76 ± 25.89 |
| Major symptoms, n (%) | ||
| Fever | 224 (100) | 296 (100) |
| Headache | 180 (80.36) | 216 (72.97) |
| Anorexia | 123 (54.91) | 135 (45.61) |
| Vomiting | 112 (50.00) | 126 (42.57) |
| Abdominal pain | 133 (59.38) | 159 (53.72) |
| Plasmodium species, n (%) | ||
| P. falciparum | 222 (99.11) | 291 (98.31) |
| P. malariae | 1 (0.45) | 4 (1.35) |
| P. ovale | 1 (0.45) | 1 (0.34) |
| P. falciparum density, mean ± SD § | 16,218 ± 9.50 | 14,739 ± 9.18 |
| ALT (IU /L), mean ± SD | 23.63 ± 11.16 | 23.61 ± 15.09 |
| AST (IU /L), mean ± SD | 29.16 ± 14.83 | 29.37 ± 15.56 |
| ALP (IU/L), mean ± SD | 225.52 ± 95.93 | 223.98 ± 92.82 |
| Total bilirubin (mg/dL), mean ± SD | 1.38 ± 1.06 | 1.24 ± 0.91 |
| Direct bilirubin (mg/dL), mean ± SD | 0.43 ± 0.29 | 0.41 ± 0.27 |
| Haemoglobin (g/dL), mean ± SD | 10.69 ± 1.48 | 10.49 ± 1.51 |
SD: Standard deviation; CI: Confidence interval; P: Plasmodium; ALP: Alkaline phosphatase; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; p: p-value; IU/L: International Units per litre; mg/dl: milligrams per decilitre; g/dl: grams per decilitre; §: geometric mean