Overview

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

Status:
COMPLETED

Trial end date:
2025-01-31

Target enrollment:

Participant gender:

Summary

This is a classical in vivo clinical trial, following World Health organization's recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and safety in four sites of artemether-lumefantrine (AL) combination for the treatment of uncomplicated malaria in children aged\<12 years. The goal of this study is to evaluate the clinical and parasitological efficacy of the study drug combinations in children aged between 6 - 143 months, suffering from uncomplicated P. falciparum malaria, by determining the proportion with early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF) or an adequate clinical and parasitological response (ACPR) as indicators of efficacy. The participants will take AL for three days and followed-up for 28 days.

Phase:

Details

Lead Sponsor:

Centro de Investigacao em Saude de Manhica

Collaborators:

Instituto Nacional de Sade, Mozambique
National Malaria Control Program (NMCP), Mozambique
World Health Organization (Mozambique)

Treatments:

Artemether, Lumefantrine Drug Combination