Table 4.
Baseline characteristics and clinical and parasitological responses in two studies conducted at the Tasanh site in Cambodiaa
| Baseline characteristic or clinical or parasitological response | Median (interquartile range) for all patients enrolled and randomized to 4 mg/kg AS for 7 days |
P value | Median (interquartile range) for only patients randomized to 4 mg/kg with a parasite density of 1,000 to 100,000/μl |
P value | ||
|---|---|---|---|---|---|---|
| Tasanh site in 2006 (n = 60) | Tasanh site in 2009 (n = 38) | Tasanh site in 2006 (n = 45) | Tasanh site in 2009 (n = 35) | |||
| Baseline characteristics | ||||||
| Age (yr) | 29.0 (20.0–44.0) | 22.0 (20.0–36.0) | 0.10 | 27.0 (20.0–41.0) | 22.0 (20.0–38.0) | 0.31 |
| Temp (°C) | 38.0 (37.0–38.9) | 38.1 (37.7–39.1) | 0.12 | 38.0 (37.2–39.2) | 38.1 (37.6–39.2) | 0.51 |
| Parasite density (no. of cells/μl) | 4,325 (982–18,643) | 24,791 (6,714–51,498) | <0.01 | 6,562 (3,892–33,452) | 23,531 (6,389–39,393) | 0.03 |
| IC50 vs dihydroartemisinin concn (μg/liter) | 1.16 (0.79–1.54) | 2.59 (1.52–3.99) | <0.01 | 1.19 (0.82–1.53) | 2.59 (1.49–4.04) | <0.01 |
| Clinical and parasitological responses | ||||||
| Cmax of dihydroartemisinin (μg/liter) | 1,226 (744–1,845) | 1,467 (889–2,126) | 0.25 | 1,345 (942–1,928) | 1,468 (894–2,184) | 0.69 |
| Patients with adequate clinical and parasitological responses (%) | 93.3 | 94.7 | 0.78 | 91.1 | 94.4 | 0.57 |
| Fever clearance time (h) | 23.8 (10.1–30.1) | 17.6 (9.65–28.8) | 0.46 | 22.9 (10.0–29.4) | 17.6 (10.0–29.2) | 0.73 |
| Parasite clearance time (h) | 62.0 (38.0–86.6) | 78.0 (64.4–96.1) | <0.01 | 66.4 (43.0–91.0) | 78.0 (61.5–96.1) | 0.18 |
| Patients with persistent parasitemia after 72 h of treatment (%) | 31.7 | 57.9 | 0.01 | 42.2 | 57.1 | 0.18 |
| P value for log rank test of Kaplan-Meier survival analysis | P = 0.02 | P = 0.41 | ||||
a
Two studies were conducted at the Tasanh site in Cambodia in 2006 (30) and 2009 (7). Here we compare the values for baseline characteristics and clinical and parasitological responses controlling for dose and enrollment parasitemia. Statistically significant differences are highlighted in boldface type with P values calculated by the Mann-Whitney U test or by the chi-squared and Fisher's exact tests where proportions were compared between treatment groups.