Triple threat: could three malaria drugs together beat resistance?
NCT ID NCT05764746
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This trial tests whether giving children with uncomplicated malaria a triple combination of artemisinin-based drugs works better than the standard two-drug treatment. The goal is to see if using three drugs together can delay the malaria parasite from becoming resistant. Children aged 6 months to 10 years with confirmed malaria will receive one of three treatment regimens and be followed for 56 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a triple combination of artemether-lumefantrine plus amodiaquine or artesunate-amodiaquine
- What this could lead to
- If successful, this approach could help delay drug resistance and keep current malaria treatments effective for longer.
- What could go wrong
- This is an early-to-mid-stage trial with 384 children, so results may not apply broadly. Combining drugs may also increase side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
384 people
The number who actually took part.
- Started
-
May 2023
- Finished
-
Jan 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 to 120 months
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Patients presenting at the health facility with suspected acute uncomplicated malaria will be screened for eligibility. Inclusion Criteria: * Age from 6 - 120 months * Weight ≥ 5 kg * Body temperature ≥37.5°C or history of fever in the last 24 hours * Microscopy confirmed P. falciparum mono-infection * Parasitemia level of 1000-200000/μL * Ability to swallow oral medication * Ability and willingness to abide by the study protocol and the stipulated follow-up visits * A written proxy informed consent from a parent/guardian Exclusion Criteria: * Children aged below 6 months will not be included in the study because ACTs are contraindicated in this group. * Evidence of severe malaria or danger signs * Known allergy to trial medicines * Reported antimalarial intake ≤2 weeks * Haemoglobin \<5 g/dL * Blood transfusion within last 90 days * Febrile condition other than malaria * Known underlying chronic or severe disease (including severe malnutrition).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Uncomplicated plasmodium falciparum malaria are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Kibindu
Bagamoyo, Dar esSalaam, 255, Tanzania
-
Yombo Dispensary
Bagamoyo, Yombo, +255, Tanzania
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug malaria punch targets faster cure in kids
- Two-Drug malaria pill combo put to the test
- New malaria combo shows promise in kids – could fight drug resistance
- New malaria pill shows promise in large trial
- New malaria combo shows promise in clearing parasite
- New malaria pill shows promise in early trial