A Study to Find Out if a Combination of 3 Medicines for the Treatment of Malaria Works as
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)
| Condition(s) | Uncomplicated Plasmodium Falciparum Malaria |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 f |
| Who can participate | 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 no |
| Ages | 6 Months |
| Sex | All |
| Lead sponsor | University of Oxford |
| Locations | Ruhuha, Eastern Province, Rwanda |
| Start date | 2025-09-11 |
| NCT ID | NCT05951595 |
| Official listing | https://clinicaltrials.gov/study/NCT05951595 |