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 Phase 3 Interventional Study
Uncomplicated Plasmodium Falciparum Malaria
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 Months and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,680 (estimated)
Sponsor
University of Oxford · Other
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About This Trial
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. Th…
Trial Locations
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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 m…
Contacts

Mehul Dhorda, Ph.D

+66 2 203-6333

mehul@tropmedres.ac

CONTACT

Arjen Dondorp, Prof.

+66 2 203-6333

arjen@tropmedres.ac

CONTACT