Comparing a New Triple-Drug Combination to Standard Two-Drug Treatments for Uncomplicated Malaria in Patients Aged 6 Months and Older

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and tolerability of a new fixed-dose triple combination therapy called artemether-lumefantrine-amodiaquine ALAQ compared to two existing artemisinin-based combination therapies ACTs for treating uncomplicated Plasmodium falciparum malaria. This open-label, randomized, controlled trial aims to determine whether ALAQ works as well and is as safe and tolerable as the current standard two-drug treatments. The study includes participants from Africa and Asia, with some sites incorporating a single low-dose primaquine treatment depending on local policies. Participants will be randomly assigned to one of three treatment groups ALAQ, artemether-lumefantrine AL, or artesunate-amodiaquine ASAQ. Treatments are given under direct observation over three days, with ALAQ and AL administered in six doses spaced between the start time and 60 hours later, while ASAQ is given once daily for three days. Participants stay in an inpatient unit for the first three days to receive treatment and undergo study procedures, followed by weekly visits up to day 42 for monitoring. During the study, researchers will perform daily malaria parasite counts, physical exams, vital sign checks, symptom questionnaires, and laboratory tests including blood counts, liver and kidney function, and heart monitoring with electrocardiograms. Pharmacokinetic studies and parasite genetic testing will also be conducted to understand drug levels and resistance patterns. Safety, efficacy at 28 and 42 days, and treatment tolerability will be closely tracked. Participants may visit the clinic between scheduled visits if they experience any symptoms. The total participation lasts up to 42 days from treatment start.

A Study to Find Out if a Combination of 3 Medicines for the Treatment of Malaria Works as Well and is as Safe and Tolerable as Combinations of 2 Medicines