Table 2. Patient clinical and laboratory findings on admission in intention-to-treat population.
| Variable | Arm | Total (n = 1,047) | ||
|---|---|---|---|---|
| Three-Dose i.v. (n = 351) | Three-Dose i.m. (n = 348) | Five-Dose i.m. (n = 348) | ||
| Clinical findings | ||||
| Female | 162 (46%) | 166 (48%) | 168 (48%) | 496 (47%) |
| Male | 189 (54%) | 182 (52%) | 180 (52%) | 551 (53%) |
| Age, y | 4.0 (2.4) | 4.1 (2.5) | 4.2 (2.5) | 4.1 (2.5) |
| Aged 0–3 y | 201 (57%) | 185 (53%) | 185 (53%) | 571 (54%) |
| Aged 4–7 y | 122 (35%) | 132 (38%) | 130 (37%) | 384 (37%) |
| Aged >8 y | 28 (8%) | 31 (9%) | 33 (10%) | 92 (9%) |
| Pulse, beats/minute | 134 (26) | 133 (25) | 133 (25) | 133 (25) |
| Respirations/minute | 40 (13) | 39 (11) | 40 (13) | 40 (12) |
| Temperature, °C | 38.2 (1.2) | 38.1 (1.2) | 38.1 (1.2) | 38.1 (1.2) |
| Weight, kg | 14.3 (5.3) | 14.3 (5.0) | 14.8 (5.1) | 14.4 (5.5) |
| Laboratory findings | ||||
| Parasitemia per microliter × 10−3 * | 129.0 (4.6–2,965.0) | 114.0 (5.0–1,439.0) | 119.0 (4.1–2,675.0) | 121.0 (4.1–2,965.0) |
| Hb, g/dl | 8.5 (2.4) | 8.7 (2.3) | 8.7 (2.4) | 8.6 (2.4) |
| White blood cell count, 103/μl | 10.3 (5.5) | 10.1 (5.2) | 9.7 (4.6) | 10.0 (5.1) |
| Neutrophils, 103/μl | 5.5 (3.2) | 5.3 (3.0) | 5.4 (3.3) | 5.4 (3.2) |
| Platelet count, 103/mm3 | 115 (117) | 107 (108) | 123 (130) | 115 (119) |
| Clinical signs of severe malaria | ||||
| Severe anemia | 34 (10%) | 42 (12%) | 40 (11%) | 116 (11%) |
| Hyperlactatemia | 21 (6%) | 18 (5%) | 23 (7%) | 62 (6%) |
| Hyperparasitemia | 103 (29%) | 91 (26%) | 103 (30%) | 297 (28%) |
| Hypoglycemia | 13 (4%) | 7 (2%) | 18 (5%) | 38 (4%) |
| Jaundice | 28 (8%) | 29 (8%) | 25 (7%) | 82 (8%) |
| Hemoglobinuria | 6 (2%) | 6 (2%) | 7 (2%) | 19 (2%) |
| Respiratory distress | 30 (9%) | 35 (10%) | 28 (8%) | 93 (9%) |
| Severe vomiting | 25 (7%) | 36 (10%) | 26 (7%) | 87 (8%) |
| Prostration | 169 (48%) | 160 (46%) | 140 (40%) | 469 (45%) |
| Cerebral malaria | 32 (9%) | 28 (8%) | 23 (7%) | 83 (8%) |
| Generalized seizures | 39 (11%) | 44 (13%) | 28 (8%) | 111 (11%) |
Data are given as mean (standard deviation) or n (percent), except for parasitemia per milliliter, which is given as geometric mean (range). Clinical classification was according to the following definitions: severe anemia (hematocrit of <15% or Hb < 5 g/dl with a parasite density of >10,000/μl), hyperlactatemia (≥5 mmol/l), hyperparasitemia (>250,000 parasites/μl), hypoglycemia (whole blood or plasma glucose ≤ 2.2 mmol/l), and hemoglobinuria (urine that is dark red or black, with a dipstick that is positive for Hb/myoglobin).
*PP population.