A Study to Find Out if a Combination of 3 Medicines for the Treatment of Malaria Works as Well and is as Safe and Tolerable as Combinations of 2 Medicines
Recruiting now · Phase 3
Conditions studied: Uncomplicated Plasmodium Falciparum Malaria
In brief
The goal of this open-label randomised, controlled, non-inferiority trial is to assess and compare the efficacy, tolerability and safety of a fixed dose TACT artemether-lumefantrine-amodiaquine (ALAQ) to the ACTs artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ) (with single low-dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria in patient. The main question it aims to answer is whether ALAQ, a fixed dose TACT, is as efficacious, safe and tolerable in comparison with AL and ASAQ. Participants will be enrolled, admitted and randomised to receive the study drug (ALAQ, AL or ASAQ). Patients will receive directly observed treatments and will be followed up at least once daily for the first 3 days after enrolment followed by weekly visits from D7 up to D42. Patients will be asked to report to the clinics between scheduled visits in case of any illness or other symptoms or complaints.
Key facts
- Study ID
- NCT05951595
- Run by
- University of Oxford
- People needed
- 1680
- Starts
- 2025-09-11
- Expected to finish
- 2026-07-31
- Last updated by the study team
- 2025-11-18
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Ruhuha Health Centre — Ruhuha, Eastern Province, Rwanda (enrolling)
Full record on ClinicalTrials.gov
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