Table 1.
Demographic and Baseline Clinical Characteristics by Treatment Arm
| Characteristic | Acetaminophen (n = 31) | Control (n = 31) |
|---|---|---|
| Demographics | ||
| Sex (male) | 19 (61) | 21 (68) |
| Age (years) | 28 (20–43) | 32 (25–40) |
| Fever before enrollment (days) | 7 (4–10) | 7 (5–8) |
| Altered level of consciousness before enrollment (days) | 2.5 (1.0–3.0) | 1.0 (1.0–2.5) |
| Red or black urine before enrollment | 0 (0) | 4 (13) |
| Acetaminophen before enrollmenta | 1 (3) | 0 (0) |
| Comorbidities | ||
| Hypertension | 3 (10) | 1 (3) |
| Coronary artery disease | 3 (10) | 1 (3) |
| Diabetes | 1 (3) | 0 (0) |
| Complications on enrollment | ||
| Comab | 10 (32) | 13 (42) |
| Jaundice | 3 (10) | 5 (16) |
| Severe anemia | 2 (6) | 2 (6) |
| Hyperlactatemia (lactate >4 mmol/L) | 7 (23) | 9 (29) |
| Hyperparasitemia (>10%) | 1 (3) | 4 (13) |
| Hemoglobinuria | 2 (7) | 6 (19) |
| Pulmonary edema | 0 (0) | 1 (3) |
| Severe prostrationc | 18 (58) | 19 (61) |
| Unable to tolerate oral medications | 22 (71) | 24 (77) |
| Severity | ||
| Severe malaria | 24 (77) | 25 (81) |
| Moderately severe malaria | 7 (23) | 6 (19) |
| Number of severity criteria | 3 (1–5) | 4 (1–6) |
| Kidney Disease: Improving Global Outcomes stage on enrollment | ||
| 0 | 17 (55) | 17 (55) |
| 1 (≥1.5 × baseline) | 7 (23) | 6 (19) |
| 2 (≥2.0–2.9 × baseline) | 3 (10) | 3 (10) |
| 3 (≥3 × baseline) OR (≥353.6 μmol/L) | 4 (13) | 5 (16) |
Data are number (%) or median (interquartile range), unless otherwise indicated. There were no significant differences between treatment groups in any of the measured baseline characteristics.
aAcetaminophen before enrollment was based on an acetaminophen concentration >10 mg/L in enrollment pharmacokinetic samples.
bDepth of coma was assessed by Glascow coma score <11.
cSevere prostration defined as inability to walk or sit up without assistance.