The safety and efficacy of the two most widely used fixed-dose @entity507 -based combination therapies (ACT), artesunate-amodiaquine ( @entity68458 ) and artemether-lumefantrine (AL) are well established for single episodes of uncomplicated @entity3964 @entity311 , but the effects of repeated, long-term use are not well documented. We conducted a 2-year randomized, open-label, longitudinal, phase IV clinical trial comparing the efficacy and safety of fixed-dose @entity68458 and AL for repeated treatment of uncomplicated @entity311 in @entity1 under 5 years at Nagongera Health Centre, Uganda. @entity1 were randomized to @entity68458 or AL and all subsequent @entity311 episodes were treated with the same regimen. 413 @entity1 were enrolled and experienced a total of 6027 @entity311 episodes (mean 15; range, 1-26). For the first @entity311 episode, the PCR-corrected-cure rate for @entity68458 (97.5%) was non-inferior to that for AL (97.0%; 95% CI [-0.028; 0.037]). PCR-corrected cure rates for subsequent @entity311 episodes that had over 100 cases (episodes 2-18), ranged from 88.1% to 98.9% per episode, with no clear difference between the treatment arms. Parasites were completely cleared by day 3 for all @entity311 episodes and gametocyte carriage was less than 1% by day 21. Fever clearance was faster in the @entity68458 group for the first episode. Treatment compliance for subsequent episodes (only first dose administration observed) was close to 100%. Adverse events though common were similar between treatment arms and mostly related to the disease. Serious adverse events were uncommon, comparable between treatment arms and resolved spontaneously. @entity417 and @entity1398 occurred in <0.5% of cases per episode, @entity409 tests occurred in 0.3% to 1.4% of cases. Both regimens were safe and effective for repeated treatment of @entity311 . TRIAL REGISTRATION: Current Controlled Trials NCT00699920.

Efficacy and Safety of Fixed-Dose Artesunate-Amodiaquine vs. Artemether-Lumefantrine for Repeated Treatment of Uncomplicated Malaria in Ugandan XXXX .

@entity1 :: ('9606', 'Species') :: ['children', 'Participants'] @entity417 :: ('MESH:D000740', 'Disease') :: ['Anemia'] @entity409 :: ('MESH:D008107', 'Disease') :: ['abnormal liver function'] @entity68458 :: ('MESH:C086083', 'Chemical') :: ['ASAQ'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity507 :: ('MESH:C031327', 'Chemical') :: ['artemisinin'] @entity3964 :: ('5833', 'Species') :: ['Plasmodium falciparum'] @entity311 :: ('MESH:D008288', 'Disease') :: ['malaria']
@entity1 :: (9606,Species) :: ['Children']
