CompletedNot Applicable

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

Mozambique352 participantsStarted 2024-03-07

Plain-language 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.

Who can participate

Age range

6 Months – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ages 6 to 143 months * Weight Greater than or equal to 5 kg * Absence of severe malnutrition; * Mono-infection with Plasmodium falciparum in blood, confirmed by microscopy; * Parasite density between 1,000 and 200,000 asexual parasites per microliter of blood; * Haemoglobin ≥ 7.0 g/dl; * Axillary temperature ≥ 37.5 C° or history of fever in the last 24 hours; * Lack of danger signs, or no signs of severe and / or complicated malaria according to the WHO definition * Ability to swallow the drugs * Residents within the study area and have the possibility of an adequate follow-up in the days of monitoring for a period of 28 days; * Absence of a history of hypersensitivity to study medications; * Informed consent of parents, guardians or caregivers (legal guardian) after explaining the purpose of the study. Exclusion Criteria: * Presence of any danger sign or severe or complicated Plasmodium falciparum malaria according to WHO definitions; * Presence of fever due to diseases other than malaria (eg measles, acute respiratory infection, severe diarrhea with dehydration) or other known diseases, with chronic or serious illnesses (cardiac, renal, hepatic or known infection with HIV AIDS); * Presence of severe malnutrition (defined as a child whose growth pattern is below the 3rd percentile, mid-upper-arm circumference \<110mm, weight / height \<70% according to the WHO tables, or the presence of bilateral edema of the lower limbs); * Multi or mono-infection b…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measuring the Day 28, PCR corrected cure rates of artemether-lumefantrine.

Timeframe: 28 days

Trial details

NCT IDNCT06970600

SponsorCentro de Investigacao em Saude de Manhica

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-28

View on ClinicalTrials.gov More Malaria (Uncomplicated) trials