Table 1.
Baseline characteristics of study participants
| Variable | AL + PQ | AL + placebo | DHAPP + PQ | DHAPP + Placebo | Total |
|---|---|---|---|---|---|
| Number of participants | N = 286 | N = 286 | N = 283 | N = 282 | N = 1137 |
| Age in yearsa | 5.0 (3.0, 7.0) | 5.0 (3.0, 7.0) | 5.0 (3.0, 8.0) | 5.0 (2.0, 8.0) | 5.0 (3.0, 8.0) |
| Sexb | |||||
| Female | 122 (42.7) | 114 (39.9) | 110 (38.9) | 124 (44.0) | 470 (41.3) |
| Male | 164 (57.3) | 172 (60.1) | 173 (61.1) | 158 (56.0) | 667 (58.7) |
| Length of illness before treatment (days)a | 2.0 (1.0, 3.0) | 2.0 (2.0, 3.0) | 2.0 (2.0, 3.0) | 2.0 (2.0, 3.0) | 2.0 (2.0, 3.0) |
| Fever (core temperature ≥ 38 °C)b | 80 (28.0) | 74 (25.9) | 75 (26.5) | 63 (22.4) | 292 (25.7) |
| Mid-upper arm circumference (cm)ac | 15.6 (14.5, 17.0) [11.0, 23.0] | 15.6 (14.5, 17.0) [12.0, 28.0] | 15.8 (14.5, 17.0) [12.0, 24.0] | 15.5 (14.5, 16.8) [12.5, 21.0] | 15.6 (14.5, 17.0) [11.0, 28.0] |
| Weight (Kg)ac | 17.0 (12.8, 22.5) [5.9, 39.0] | 17.0 (12.0, 22.0) [6.6, 41.5] | 17.0 (12.9, 23.4) [6.6, 43.0] | 16.5 (12.7, 22.0) [6.6, 35.7] | 17.0 (12.7, 22.1) [5.9, 43.0] |
| Splenomegalyb | 69 (24.1) | 58 (20.3) | 68 (24.0) | 71 (25.2) | 266 (23.4) |
| Hepatomegalyb | 16 (5.6) | 15 (5.2) | 14 (4.9) | 11 (3.9) | 56 (4.9) |
| Microscopyb | |||||
| Positive slide result | 249 (87.1) | 251 (87.8) | 239 (84.5) | 246 (87.2) | 985 (86.6) |
| Negative slide result | 37 (12.9) | 35 (12.2) | 44 (15.5) | 35 (12.5) | 151 (13.3) |
| Mixed infection with | |||||
| P. malariae n | 5 | 5 | 4 | 3 | 17 |
| P. ovale n | - | - | - | 1 | 1 |
| Asexual parasitaemia (/μL)d | 13,873 [7.2, 1,397,958.0] | 12,345 [14.0, 1,100,764.0] | 14,148 [12.0, 668,769.8] | 18,848 [7.4, 2,172,060.0] | 14,599 [7.2, 2,172,060.0] |
| Gametocytaemia (/μL) d | 52.6 [8.2, 1778.4] | 36.9 [7.8, 2028.0] | 49.9 [10.0, 2316.6] | 44.0 [8.8, 2888.4] | 45.5 [7.8, 2888.4] |
| Haemoglobin (g/dL)e | 10.5 (1.7) | 10.7 (1.5) | 10.7 (1.6) | 10.5 (1.6) | 10.6 (1.6)f |
| Haematocrit (%) e | 31.0 (4.5) | 31.5 (4.2) | 31.7 (4.7) | 30.9 (4.5) | 31.3 (4.5) |
| G6PD statusb | |||||
| Normal | 176 (62.6) | 186 (65.3) | 174 (63.0) | 181 (65.1) | 717 (64.0) |
| Heterozygous female | 32 (11.4) | 32 (11.2) | 24 (8.7) | 31 (11.2) | 119 (10.6) |
| Deficient males and females | 73 (26.0) | 67 (23.5) | 78 (28.3) | 66 (23.7) | 284 (25.4) |
| Sickle cell statusb | |||||
| Normal (HbAA) | 248 (87.9) | 243 (85.3) | 234 (84.2) | 231 (83.4) | 956 (85.2) |
| Trait (HbAS) | 33 (11.7) | 42 (14.7) | 42 (15.1) | 46 (16.6) | 163 (14.5) |
| Disease (HbSS) | 1 (0.4) | 0 (0.0) | 2 (0.7) | 0 (0.0) | 3 (0.3) |
| Thalassaemiab | |||||
| Normal (αα/αα) | 132 (46.8) | 139 (48.9) | 124 (45.6) | 136 (48.9) | 531 (47.6) |
| Heterozygous (-α/αα) | 124 (44.0) | 122 (43.0) | 122 (44.9) | 109 (39.2) | 477 (42.7) |
| Homozygous (-α/-α) | 26 (9.2) | 23 (8.1) | 26 (9.6) | 33 (11.9) | 108 (9.7) |
| Primaquine/placebo dose | 0.21 (0.17, 0.25) | 0.21 (0.18, 0.25) | 0.20 (0.17, 0.25) | 0.22 (0.18, 0.25) | 0.21 (0.17, 0.25) |
| (mg/kg)ac | [0.11, 0.37] | [0.12, 0.35] | [0.07, 0.41] | [0.07, 0.38] | [0.07, 0.41] |
aMedian (IQR)
bn (%)
cRange [minimum, maximum]
dGeometric mean [range]
eMean (SD)
f10.0 (1.5) g/dL (age < 5 years) vs. 11.1(1.5) g/dL (age 5–11 years), p < 0.001