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
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Medical Care Development Global health (MCD)
interventional
352
1 country
4
Study Start
March 7, 2024
Actual (reported)Primary Completion
October 28, 2024
Actual (reported)Study Completion
January 31, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 7, 2024
Actual (reported)October 28, 2024
Actual (reported)January 31, 2025
Actual (reported)May 6, 2025
Actual (reported)May 14, 2025
Actual (reported)Measuring the Day 28, PCR corrected cure rates of artemether-lumefantrine.
This cure rate is defined as the proportion of patients with adequate clinical and parasitological response (ACPR) at Day 28, once PCR correction to differentiate recrudescences from new infections have been applied (and hence only considering as treatment failures those parasite recurrences confirmed as recrudescences).
28 days
To evaluate the incidence of adverse events
28 days
To evaluate the variation of the levels of haemoglobin during and after treatment
28 days
Measuring the Day PCR uncorrected cure rates of Artemether-Lumefantrine.
28 days
Evaluate the presence of Molecular Markers associated with sub optimum responses to ACTs
28 days
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Distrital de Massinga
Massinga, Inhambane Province, Mozambique
Hospital Rural de Cuamba
Cuamba, Niassa Province, Mozambique
Hospital Distrital de Dondo
Dondo, Sofala, Mozambique
Hospital Distrital de Mopeia
Mopeia, Zambezia Province, Mozambique
Pedro Aide, MD, Msc, PhD
Centro de Investigaçao em Saude de Manhiça
352 participants (actual enrollment reported by the registry).
First Submitted
May 6, 2025
First Posted
May 14, 2025
Study Start
March 7, 2024
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 28, 2024
Actual (reported)Study Completion
January 31, 2025
Actual (reported)Last Updated
May 14, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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