Table 1. Baseline characteristics of patients enrolled into the study.
All patients diagnosed with G6PD deficiency by FST | Subgroup of patients with G6PD deficiency confirmed by genotyping | G6PD normal patients enrolled in the randomised trial | |||
---|---|---|---|---|---|
PQ 8 weeks | PQ 8 weeks | Placebo | PQ7days | PQ14days | |
N = 50 | N = 31 | N = 464 | N = 935 | N = 937 | |
Patients enrolled N (%) | |||||
Afghanistan | 6 (12.0%) | 5 (16.1%) | 83 (17.9%) | 173 (18.5%) | 175 (18.6%) |
Ethiopia | 5 (10.0%) | 4 (12.9%) | 114 (24.5%) | 234 (25.0%) | 232 (24.8%) |
Indonesia | 19 (38.0%) | 6 (19.4%) | 203 (43.7%) | 400 (42.8%) | 397 (42.3%) |
Vietnam | 20 (40.0%) | 16 (51.6%) | 64 (13.8%) | 128 (13.7%) | 133 (14.2%) |
Age in years, median (IQR) [range] | 23.0 (14.0–38.0) [0.0–60.0] | 20.0 (14.0–36.0) [0.8–60.0] | 17.0 [10.0–28.0] | 16.0 [10.0–25.0] | 16.0 [10.0–26.0] |
Age category months (m) or years(y) | |||||
6–11 m | 1 (2.0%) | 1 (3.2%) | 1 (0.2%) | 1 (0.1%) | 1 (0.1%) |
≥1 & <5 y | 3 (6.0%) | 2 (6.5%) | 28 (6.0%) | 60 (6.4%) | 63 (6.7%) |
≥5 & <15 y | 10 (20.0%) | 7 (22.6%) | 163 (35.1%) | 358 (38.3%) | 335 (35.8%) |
≥15 y | 36 (72.0%) | 21 (67.7%) | 272 (58.6%) | 516 (55.2%) | 538 (57.4%) |
Sex | |||||
Male | 42 (84.0%) | 26 (83.9%) | 296 (63.8%) | 563 (60.2%) | 608 (64.9%) |
Female | 8 (16.0%) | 5 (16.1%) | 168 (36.2%) | 372 (39.8%) | 329 (35.1%) |
Weight in kg median (IQR) | 51.0 (36.0–60.3) | 48.8 (35.5–60.0) | 47.0 [26.4–57.5] | 46.2 [26.0–57.0] | 46.8 [25.3–56.6] |
Weight category | |||||
10–22 kg | 7 (14.0%) | 5 (16.1%) | 3 (0.6%) | 8 (0.9%) | 6 (0.6%) |
23–34 kg | 4 (8.0%) | 2 (6.5%) | 89 (19.2%) | 180 (19.3%) | 180 (19.2%) |
34–45 kg | 6 (12.0%) | 5 (16.1%) | 67 (14.4%) | 136 (14.5%) | 143 (15.3%) |
46+ kg | 33 (66.0%) | 19 (61.3%) | 64 (13.8%) | 135 (14.4%) | 121 (12.9%) |
P. vivax parasites/uL geometric mean (95% normal range) | 2947 (70–25000) | 2555 (67–67500) | 3702 (150–53057) | 3330 (144–55000) | 3426 (137–50000) |
Gametocytaemia | 37 (74.0%) | 23 (74.2%) | 335 (72.2%) | 713 (76.3%) | 704 (75.1%) |
Gametocytes/uL geometric mean (95% normal range) | 138.2 (15.0–3593) | 98 (15–1204) | 211 (15–3037) | 200 (15–3815) | 198 (15–2545) |
Temperature(°C) Mean [SD] | 37.7 [1.2] | 37.8 (1.3) | 37.9 [1.2] | 37.8 [1.2] | 37.8 [1.2] |
Fever (Axillary >37.5C or Oral >38C) N (%) | 25 (50.0%) | 17 (54.8%) | 267 (57.9%) | 537 (57.9%) | 538 (57.5%) |
Hemoglobin (g/dL) Mean [SD]† | 13.5 [1.9] | 13.1 [1.8] | 13.0 [1.7] | 13.0 [1.8] | 12.9 [1.7] |
Hb <10 g/dL | 3 (6.0%) | 2 (6.5%) | 19 (4.1%) | 30 (3.2%) | 40 (4.3%) |
The baseline characteristics of patients enrolled at each site are presented in S6 Table