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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

Study acronym: FD-TACT
StatusRecruiting
PhasePhase 3
Started
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Record status
This record was last updated November 18, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 7 more changesShow less
    • Primary completion date: Nov 30, 2024 to Jul 31, 2026
    • Start date changed from estimate of Jan 1, 2024 to Sep 11, 2025
    • Enrollment target: 1440 to 1680
    • Study sites: 0 to 1
    • Study completion date: May 31, 2025 to Jul 31, 2026
    • Eligibility criteria expanded, about 6 words
    • Study description expanded, about 53 words
  2. Study description shortened, about 11 wordsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05951595
Lead Sponsor University of Oxford
Conditions
(from sponsor)		 Uncomplicated Plasmodium Falciparum Malaria
Enrollment 1,680 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov