Table 2. Treatment Outcomes; Parasite and Fever Clearance.
| Variable | AL Arm (n = 58) | CQ Arm (n = 65) | P Value |
|---|---|---|---|
| Adequate parasitological and clinical response, No./total (%)a | |||
| Day 28 | 48/48 (100) | 57/57 (100) | … |
| Day 42 | 46/46 (100) | 53/53 (100) | … |
| Parasitological response: any parasitemia | |||
| 24 h | |||
| Negative results, No. (%; 95% CI) | 44 (76; 63–86) | 39 (60; 47–72) | .06 |
| Difference in risk (95% CI), % | 16 (0–32) | … | |
| Risk ratio (95% CI) | 1.3 (1.0–1.6) | … | |
| 48 h | |||
| Negative results, No. (%; 95% CI) | 58 (100; 93.8–100) | 65 (100; 94.5–100) | … |
| PCT, median (IQR) [range], h | 18 (18–24) [6–42] | 24 (18–30) [12–48] | .02b |
| Parasitological response: parasitemia >1000/μLa | n = 35 (60%) | n = 38 (58%) | |
| 24 h | |||
| Negative results, No. (%; 95% CI) | 22 (63; 46–80) | 15 (40; 23–56) | .047b |
| Difference in risk (95% CI), % | 23 (0–46) | … | |
| Risk ratio (95% CI) | 1.6 (1.0–2.5) | … | |
| 48 h | |||
| Negative results, No. (%; 95% CI) | 35 (100; 90.0–100) | 38 (100; 90.7–100) | … |
| PCT, median (IQR) [range], h | 24 (18–30) [12–42] | 30 (24–36) [12–48] | .02b |
| Slope of curve for log10-normalized parasite clearance mean (95% CI), kc | 0.27 (.25–.29) | 0.22 (.20–.24) | .002b |
| Lag phase present, No. (%) | 14 (40.0) | 13 (34.2) | .61 |
| Lag phase duration, mean (95% CI), h | 2.9 (1.6–4.3) | 2.5 (1.3–3.7) | .81 |
| PCT, mean (95% CI), h | |||
| 50% PCTd | 7.2 (5.6–8.9) | 8.2 (6.4–10.1) | .51 |
| 90% PCT | 13.7 (11.8–15.7) | 15.6 (13.6–17.7) | .14 |
| 99% PCT | 23.1 (20.3–25.8) | 26.9 (24.2–29.6) | .03b |
| Fever clearance time, median (IQR) [range], h | 18 (12–24) [6–60] | 12 (12–30) [6–48] | .87 |
Abbreviations: AL, artemether-lumefantrine; CI, confidence interval; CQ, chloroquine; IQR, interquartile range; PCT, parasite clearance time.
a
Adequate parasitological and clinical response is defined elsewhere [21].
b
Significant difference (P < .05).
c
Including only those with parasite counts >1000/μL according to the WorldWide Antimalarial Resistance Network (WWARN) parasite clearance method [29].
d
Reduction in parasite count by 50%.