NCT05951595 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
| NCT ID | NCT05951595 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Oxford |
| Condition | Uncomplicated Plasmodium Falciparum Malaria |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,680 participants |
| Start Date | 2025-09-11 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,680 participants in total. It began in 2025-09-11 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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)
Contact & Investigator
Mehul Dhorda, Ph.D
PRINCIPAL INVESTIGATOR
Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
Frequently Asked Questions
Who can join the NCT05951595 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, studying Uncomplicated Plasmodium Falciparum Malaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05951595 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,680 participants.
Is NCT05951595 currently recruiting?
Yes, NCT05951595 is actively recruiting participants. Contact the research team at mehul@tropmedres.ac for enrollment information.
Where is the NCT05951595 trial being conducted?
This trial is being conducted at Ruhuha, Rwanda.
Who is sponsoring the NCT05951595 clinical trial?
NCT05951595 is sponsored by University of Oxford. The principal investigator is Mehul Dhorda, Ph.D at Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. The trial plans to enroll 1,680 participants.