Ngenda

Researchers are evaluating the safety, tolerability, and effectiveness of a new fixed-dose triple combination therapy called artemether-lumefantrine-amodiaquine (ALAQ) compared to two other standard treatments for uncomplicated Plasmodium falciparum malaria. This open-label, randomized, controlled, non-inferiority Phase 3 trial aims to determine if ALAQ works as well and is as safe as artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ), with some sites also including a single low-dose primaquine as recommended by the World Health Organization. The study will enroll 1,680 participants across Africa and Asia, focusing on patients with uncomplicated P. falciparum infection. Participants will be randomly assigned to receive one of the treatments: the triple combination ALAQ, AL, or ASAQ. The treatments are given over three days with specific dosing schedules; ALAQ and AL are administered in six doses at specific hours (H0, H8, H24, H36, H48, H60), while ASAQ is given once daily for three days. Participants will be admitted for three days for directly observed treatment and study procedures, then followed weekly from day 7 to day 42. In some settings, primaquine may be added as a single dose for patients weighing 10 kg or more. During the study, participants will undergo daily parasite monitoring during admission and weekly assessments afterward, including blood tests, physical exams, symptom questionnaires, and electrocardiograms to monitor heart effects. Safety tests will assess kidney and liver function, blood counts, and heart rhythms. Blood samples will also be collected to study parasite genetics and drug sensitivity. Pharmacokinetic studies will be conducted in some participants to understand drug levels and effects. Participants will be asked to report any illness between visits. The primary outcome is the treatment's efficacy measured over 28 days.