Results
malaria, dengue fever, vomiting, infection, malaria infection, parasitaemia, hepatocellular carcinoma, hypoglycaemia
MALARIA, ADVERSE EVENTS, DENGUE FEVER, INFECTION, HEPATOCELLULAR CARCINOMA, SAID, HYPOGLYCAEMIA
Between March 11 and Nov 20, 2020, a total of 1613 people were screened and 1480 enrolled (Trial profile*Within the intention-to-treat population, there were 713 complete cases in the artemether–lumefantrine group and 714 complete cases in the multivitamin group.Baseline characteristicsData are median (IQR), n (%), or mean (SD).History within previous 5 years.At screening.The proportion of participants who had parasitaemia detected by PCR at baseline was similar in both treatment groups (83 [11%] of 738 in the artemether–lumefantrine group and 86 [12%] of 742 in the multivitamin group). 713 participants in the artemether–lumefantrine group and 714 in the multivitamin group had a PCR result or confirmed clinical malaria by RDT during follow-up. Over the whole follow-up period, there were 14 episodes due to Percentage of participants with malaria infection over timeMalaria infection was defined as PCR parasite positivity on days 0 (baseline), 28–35 (month 1), 56–63 (month 2), or 84–91 (month 3), or a case of confirmed clinical malaria during month 1, month 2, or month 3.The proportion of participants who had symptomatic or asymptomatic The proportion of participants who had symptomatic or asymptomatic Overall loss to follow-up during months 1, 2, and 3, respectively, was 5% (39 of 738), 7% (44 of 629), and 8% (48 of 569) in the artemether–lumefantrine group and 5% (35 of 742), 8% (53 of 649), and 7% (41 of 581) in the multivitamin group (There were no significant differences between the artemether–lumefantrine group and multivitamin group in vomiting within 1 h (Treatment course uptake and adverse eventsData are n, n/N (%), or n (%).Comparing between groups using Fisher's exact test.All participants (738 in the artemether–lumefantrine group, 742 in the multivitamin group) took the first dose after enrolment; for 22 and 21 participants, respectively, it was not recorded that they took any further doses.The denominator for the percentages is the total number of doses taken in each group (18 806 in the artemether–lumefantrine group, 19 312 in the multivitamin group).Serious adverse events included one case of dengue fever and one case of hypoglycaemia in the artemether–lumefantrine group, and one suspected hepatocellular carcinoma and two accidents in the multivitamin group.Median time from the last dose of artemether–lumefantrine to blood sampling for lumefantrine assessment was 1 day (IQR 1–2) for those with detectable plasma lumefantrine and 1 day (1·00–1·75) for those with undetectable plasma lumefantrine. Of 105 blood samples taken from 43 randomly selected participants from three villages in the artemether–lumefantrine group at follow-up (40 first, 37 second, and 28 third follow-up visits), 99 (94%) were positive for lumefantrine and 83 (79%) for desbutyl-lumefantrine. Five of the six participants who had no detectable plasma lumefantrine or desbutyl-lumefantrine said they had taken the artemether–lumefantrine in the correct dose with food as per the schedule, and intake had been observed by the forest team leader (smart DOT). The remaining participant said they had missed the last dose. Of the 105 participants with a drug measurement, none had a confirmed clinical episode of malaria during follow-up, and none of the six participants with undetectable lumefantrine and five (5%) of the 99 participants with detectable drug concentrations were positive by PCR for 