352
Participants
Start Date
March 7, 2024
Primary Completion Date
October 28, 2024
Study Completion Date
January 31, 2025
Artemether-lumefantrine (Coartem)
Eligible patients will be consecutively assigned to the four cohorts. Rescue therapy according to national malaria treatment guidelines will be also administered in cases of early or late treatment failure. Follow-up visits will take place on days 1, 2, 3, 7, 14,21 and 28 after enrolment or at any time point whenever the child is sick. Adverse events will be recorded and assessed for severity and association with study medication. Thick and thin Giemsa-stained blood slides will be prepared before each dose to be administered and at every follow-up visit of days 2, 3, 7, 14, 21, 28, 35 and 42. Blood samples for PCR analysis will be collected from every patient at baseline and at days 7, 14, 28, and 42 day of treatment failure or at any other unscheduled visit. To differentiate recrudescence from new infection by polymerase chain reaction (PCR) analysis.The Molecular markers associated with suboptimal response to ACTs will be investigated.
Hospital Distrital de Massinga, Massinga
Hospital Rural de Cuamba, Cuamba
Hospital Distrital de Dondo, Dondo
Hospital Distrital de Mopeia, Mopeia
World Health Organization (Mozambique)
UNKNOWN
National Malaria Control Program (NMCP), Mozambique
UNKNOWN
Instituto Nacional de Saúde, Mozambique
OTHER_GOV
Centro de Investigacao em Saude de Manhica
OTHER