Fixed-dose combination of artemether-lumefantrine-amodiaquine for uncomplicated falciparum malaria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, randomized, controlled non-inferiority Phase 3 trial comparing a fixed-dose triple artemisinin-based combination (ALAQ) with two standard two-drug ACTs (artemether-lumefantrine [AL] and artesunate-amodiaquine [ASAQ]). Eligible participants (aged ≥6 months and ≥5 kg) with uncomplicated P. falciparum infection are admitted for three days for directly observed oral treatment and daily parasitemia monitoring, then followed weekly to day 42. The overall sample size is 1,680 with a 2:1:1 randomization (840 ALAQ, 420 AL, 420 ASAQ) across African and Asian sites, and microscopy and parasite clearance assessments are performed frequently during hospitalization and follow-up. In lower-transmission settings a single low dose of primaquine may be given per WHO guidance where local policy allows.

Why it matters

Who can join: the full rules

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)

Where it's running

• Ruhuha Health Centre
  Ruhuha, Eastern Province, Rwanda Recruiting

Study contacts

• Principal investigator: Mehul Dhorda, Ph.D — Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
• Study coordinator: Mehul Dhorda, Ph.D
• Email: mehul@tropmedres.ac
• Phone: +66 2 203-6333

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.