NCT06970600

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Centro de Investigacao em Saude de Manhica · Academic / Other
• Sex: All
• Age: 6 Months – 11 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible patients were consecutively assigned to the cohort and treated with AL. AL (Coartem™) will be administered twice daily for three days (six doses in total) with dosage determined according to body weight: one tablet (20mg artemether and 120mg lumefantrine) for children 5 to \<15kg, two tablets per dose for those 15 to \<25kg, and three tablets per dose for those 25 to \<35kg. All treatments will be directly observed for a minimum of 30 minutes. Vomiting occurring within the first 30 minutes implied the repetition of the full dose of treatment. For those patients living far away from the health facilities, and for which direct observation of the evening doses of AL was challenging, admission was offered for the first three days of the study. Then after first four days, the patients were followed-up weekly ( clinical and laboratory assessment) until day 28.

Conditions

• Malaria (Uncomplicated)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-07
• Primary completion: 2024-10-28
• Completion: 2025-01-31
• First posted: 2025-05-14
• Last updated: 2025-05-14

Locations

4 sites across 1 country: Mozambique