Actively Recruiting
An Open-label, Randomised, Controlled Trial to Compare the Efficacy, Safety and Tolerability of a Triple Artemisinin-based Therapy Artemether-lumefantrine-amodiaquine Versus Standard Artemisinin-based Therapies for Uncomplicated Plasmodium Falciparum Malaria
Led by University of Oxford · Updated on 2025-11-18
1680
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, and tolerability of a new fixed-dose triple combination therapy called artemether-lumefantrine-amodiaquine (ALAQ) compared to two existing artemisinin-based combination therapies (ACTs) for treating uncomplicated Plasmodium falciparum malaria. This open-label, randomized, controlled trial aims to determine whether ALAQ works as well and is as safe and tolerable as the current standard two-drug treatments. The study includes participants from Africa and Asia, with some sites incorporating a single low-dose primaquine treatment depending on local policies. Participants will be randomly assigned to one of three treatment groups: ALAQ, artemether-lumefantrine (AL), or artesunate-amodiaquine (ASAQ). Treatments are given under direct observation over three days, with ALAQ and AL administered in six doses spaced between the start time and 60 hours later, while ASAQ is given once daily for three days. Participants stay in an inpatient unit for the first three days to receive treatment and undergo study procedures, followed by weekly visits up to day 42 for monitoring. During the study, researchers will perform daily malaria parasite counts, physical exams, vital sign checks, symptom questionnaires, and laboratory tests including blood counts, liver and kidney function, and heart monitoring with electrocardiograms. Pharmacokinetic studies and parasite genetic testing will also be conducted to understand drug levels and resistance patterns. Safety, efficacy at 28 and 42 days, and treatment tolerability will be closely tracked. Participants may visit the clinic between scheduled visits if they experience any symptoms. The total participation lasts up to 42 days from treatment start.
CONDITIONS
Brief 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 no upper age limit unless required locally
- Bodyweight of at least 5 kilograms
- Ability to take oral medication
- Fever of 38°C or higher or history of fever in last 24 hours
- Confirmed acute uncomplicated Plasmodium falciparum monoinfection
- Asexual parasite count between 1,000/µL and 250,000/µL on blood film
- Written informed consent from participant or parent/guardian
- Willingness and ability to follow study protocol until completion
You will not qualify if you...
- Signs of severe malaria or need for intravenous antimalarial treatment
- Hemoglobin level below 7 g/dL at screening
- Use of artemisinin or derivatives within past 7 days, or lumefantrine or amodiaquine within past 14 days
- Use of seasonal malaria chemoprophylaxis in last 30 days where applicable
- Acute illness other than malaria requiring systemic treatment
- Severe acute malnutrition
- Known HIV, tuberculosis, COVID-19, or other severe infections
- Pregnant, trying to get pregnant, or breastfeeding women
- History of allergy or contraindication to study drugs including neuropsychiatric disorders and epilepsy
- Previous removal of spleen
- Participation in another interventional study within past 3 months or ongoing follow-up for such studies, including FD-TACT study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants are admitted for three days to an in-patient unit for directly observed treatment with one of the study drug combinations and to perform all required study procedures.
Daily visits during hospitalization
Duration - Up to 6 weeks
Participants are followed weekly after discharge to monitor recovery, efficacy, and safety until day 42.
Weekly visits from Day 7 to Day 42
Trial Site Locations
Total: 1 location
1
Ruhuha Health Centre
Ruhuha, Eastern Province, Rwanda
Actively Recruiting
Research Team
M
Mehul Dhorda, Ph.D
A
Arjen Dondorp, Prof.
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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