Efficacy of Artemether-Lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 12 Years at Four Sentinel Sites in Mozambique

NACompletedINTERVENTIONAL
Enrollment

352

Participants

Timeline

Start Date

March 7, 2024

Primary Completion Date

October 28, 2024

Study Completion Date

January 31, 2025

Conditions
Malaria (Uncomplicated)
Interventions
DRUG

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.

Trial Locations (4)

Unknown

Hospital Distrital de Massinga, Massinga

Hospital Rural de Cuamba, Cuamba

Hospital Distrital de Dondo, Dondo

Hospital Distrital de Mopeia, Mopeia

All Listed Sponsors
collaborator

World Health Organization (Mozambique)

UNKNOWN

collaborator

National Malaria Control Program (NMCP), Mozambique

UNKNOWN

collaborator

Instituto Nacional de Saúde, Mozambique

OTHER_GOV

lead

Centro de Investigacao em Saude de Manhica

OTHER

NCT06970600 - Efficacy of Artemether-Lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 12 Years at Four Sentinel Sites in Mozambique | Biotech Hunter | Biotech Hunter