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Parasite positivity rate on Day 2 were also similar in children with recrudesce and those without recrudescence (2 of 17 [11.8%] versus 18 of 319 [5.6%], P = 0.26).
However, parasite positivity rate on Day 2 were similar in children with recrudesce and those without recrudescence (3 of 34 [8.8%] versus 33 of 666 [5%], P = 0.41).
In children treated with artesunate-amodiaquine, parasite positivity rate on Day 1 were similar in children with recrudesce and those without recrudescence (11 of 17 [64.7%] versus 169 of 346 [48.8%], P = 0.20).
In children treated with artemether-lumefantrine, parasite positivity rate on Day 1 were similar in children with recrudesce and those without recrudescence (13 of 16 [81.3%] versus 188 of 319 [58.9%], χ = 3.15, P = 0.076).
Overall, parasite positivity rate on Day 1 was significantly higher in children with recrudesce compared with those without recrudescence (24 of 33 [72.7%] versus 357 of 665 ([3%], χ = 4.59, P = 0.03 by Mantel-Haenszel test).
Parasite clearance was significantly longer in children with recrudescent infections compared with those without recrudescence (1.8 + 0.5 d, range 1 3, N = 32 versus 1.6 + 0.7 d, range 1 7, N = 587, P = 0.019).
Similar(43)
Further, this combination therapy provided protection over 35 days without any recrudescence, thus proving to be effective against resistant malaria.
The main efficacy variable was the 28-day PCR-corrected parasitologic cure rate, which was defined as the proportion of patients with clearance of asexual parasitemia within 7 days of the first dose of AL and without subsequent recrudescence within 28 days.
The median dose of artesunate was also similar in children without and with recrudescence 11.5 (mean 12.2, range 8.4 16.7 mg/kg, N = 345), versus 11.5 (mean 12.3, range 8.8 16.7, N = 17, P = 0.79 by Kruskal Wallis test).
Using intention to treat analysis with missing outcomes treated as successes, and without adjustment to distinguish recrudescence from new infections, the day 28 adequate clinical and parasitological response (ACPR) rate for SP was 25%, inferior to each of the three combination therapies (p<0.001).
Time to recrudescence was the time to recrudesce to the initial parasitemia.
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