New triple drug combo could beat malaria resistance
NCT ID NCT05951595
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new triple-drug combination (artemether-lumefantrine-amodiaquine) against standard two-drug treatments for uncomplicated malaria. About 1680 people with malaria will receive one of the treatments and be monitored for 42 days. The goal is to see if the triple therapy works as well or better, especially against drug-resistant malaria.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,680 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female, aged ≥6 months (no upper limit unless one is required by local regulations) and bodyweight ≥5 kg * Ability to take oral medication * Fever defined as ≥38°C tympanic temperature or a history of fever within the last 24 hours * Acute uncomplicated P. falciparum monoinfection * Asexual P. falciparum parasitaemia: 1,000/µL to 250,000/µL determined on a peripheral blood film * Written informed consent by the participant, or by the parent/guardian in case of children lower than the age of consent, and assent if required (per local regulations) * Willingness and ability of the participants or parents/guardians to comply with the study protocol for the duration of the study Exclusion Criteria: * Signs of severe malaria (adapted from WHO criteria) * Patients not fulfilling criteria for severe malaria but with other indication(s) for parenteral antimalarial treatment at the discretion of the treating physician * Haemoglobin \<7 g/dL at screening * Participants who have received artemisinin or a derivative within the previous 7 days OR lumefantrine or amodiaquine within the previous 14 days * In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 30 days * Acute illness other than malaria requiring systemic treatment * Severe acute malnutrition * Known HIV, tuberculosis, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or other severe infection * For women of child-bearing age: pregnant, trying to get pregnant or lactating * History of allergy or known contraindication to any of the study drugs, including neuropsychiatric disorders and epilepsy * Previous splenectomy * Participation in the previous 3 months and/or ongoing follow-up for an interventional study (including FD-TACT)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ruhuha Health Centre
RECRUITINGRuhuha, Eastern Province, Rwanda
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Two-Drug malaria pill combo put to the test
- Triple threat: could three malaria drugs together beat resistance?
- New malaria combo shows promise in kids – could fight drug resistance
- New malaria pill shows promise in large trial
- New malaria combo shows promise in clearing parasite