Actively Recruiting
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
Led by University of Oxford · Updated on 2025-11-18
1680
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 6 months or older with bodyweight at least 5 kg
- Able to take oral medication
- Fever of 38°C or higher or history of fever within the last 24 hours
- Acute uncomplicated Plasmodium falciparum monoinfection
- Parasite count between 1,000/µL and 250,000/µL on blood film
- Written informed consent from participant or guardian, and assent if required
- Willingness and ability to follow the study protocol for its duration
You will not qualify if you...
- Signs of severe malaria
- Need for parenteral antimalarial treatment as judged by physician
- Hemoglobin less than 7 g/dL at screening
- Received artemisinin or derivatives within 7 days, or lumefantrine or amodiaquine within 14 days
- Use of seasonal malaria chemoprophylaxis within last 30 days (where applicable)
- Acute illness other than malaria needing systemic treatment
- Severe acute malnutrition
- Known HIV, tuberculosis, SARS-CoV-2, or other severe infection
- Pregnant, trying to become pregnant, or breastfeeding (for women of childbearing age)
- Allergy or contraindication to study drugs, including neuropsychiatric disorders or epilepsy
- Previous splenectomy
- Participation in another interventional study in past 3 months or ongoing follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ruhuha Health Centre
Ruhuha, Eastern Province, Rwanda
Actively Recruiting
Research Team
M
Mehul Dhorda, Ph.D
CONTACT
A
Arjen Dondorp, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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