Treatments
malaria, vomiting, fatty meal
MALARIA
The study drugs were administered orally for 3 days (days 0, 1, and 2). PA (Pyramax™—Shin Poong Pharmaceutical Company, Ltd., Ansan, Korea) was given once daily in the clinic by the research nurse supervised for 3 days. Pyramax™ contains 60 mg pyronaridine/20 mg artesunate per sachet of granules and 180 mg pyronaridine/60 mg artesunate per tablet supplied in aluminum sachets. Dosing was based on body weight: 5—< 8 kg: one sachet; 8—< 15 kg: two sachets; 15—< 20 kg; three sachets; 20—< 24 kg: one tablet and 24—< 45 kg: two tablets. All PA doses were administered with a milk drink under the supervision of a research nurse. AL was administered as dispersible tablets (Coartem™, Novartis Pharma Basil Switzerland). Each dispersible tablet contains 20 mg of artemether/120 mg of lumefantrine. Study participants were dosed as follows: 5—< 15 kg; one tablet, 15—< 25 kg two tablets, 25—< 35 kg three tablets, and 35 kg and above; four tablets. AL was administered at 0, 8, 24, 36, 48, and 60 h respectively. The first, third, and fifth doses of AL were administered supervised in the clinic with milk drinks while the second, fourth, and sixth doses of AL were administered with milk drinks at home by the parent or guardian. Mothers of children who received AL were encouraged to breastfeed very young babies who were still on the breast soon after the drug was administered. At the end of Days 0, 1, and 2 visits, parents and guardians were given a sachet of full cream powdered milk each daily for the 2nd, 4th, and 6th doses of AL and were also reminded by phone 30 min before the next drug dosing. Although a fatty meal was not required for optimal absorption of PA unlike for AL, all enrollees received study drugs with milk drinks because the children who were randomized to receive PA felt disadvantaged because they did not receive milk drinks, and this could lead to poor compliance with follow up visits.Each enrollee irrespective of drug group was observed in the clinic for one hour after drug administration for vomiting. If vomiting occurred within 30 min of drug administration, the full treatment drug dose (PA or AL) was re-administered. If vomiting occurred between 30 and 60 min of drug administration, half the treatment dose was re-administered. Any enrollee who vomited the repeat dose was withdrawn from the study and treated with artesunate-amodiaquine (ASAQ) as rescue medication as per the Nigeria national malaria treatment guidelines [