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Triple threat: new malaria cocktail aims to outsmart resistance

NCT ID NCT03923725

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large Phase 3 trial tested whether combining three antimalarial drugs works better than the standard two-drug treatments for uncomplicated malaria in African children. Over 2,500 children aged 6 months to 12 years received either a triple or standard therapy. The goal was to see if the triple combinations are at least as good at clearing the parasite and preventing its return within 42 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
artemether-lumefantrine plus amodiaquine (AL+AQ) and artesunate-mefloquine plus piperaquine (ASMQ+PPQ)
What this could lead to
If successful, these triple-drug combinations could offer a more effective treatment for malaria, potentially reducing the risk of drug resistance.
What could go wrong
This is a completed Phase 3 trial, but results may not show a clear benefit over standard treatments. Adding more drugs could 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,583 people

The number who actually took part.

Started

Sep 2020

Finished

Mar 2024

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 months to 12 years

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female, aged ≥6 months to \<12 years (For Gambia, Rwanda sites only: ≥6 months) * Ability to take oral medication * Acute uncomplicated P. falciparum monoinfection * Asexual P. falciparum parasitaemia: 1,000/µL to ≤10% parasitaemia, determined on a peripheral blood film (At Gambia, Rwanda sites only: For subjects ≥12 years - 1000/µL to 200,000/µL) * Fever defined as ≥ 37.5°C tympanic temperature or a history of fever within the last 24 hours * Written informed consent by the subject or by parent/guardian in case of children lower than the age of consent and assent if required (per local regulations) * Willingness and ability of the subjects or parents/guardians to comply with the study protocol for the duration of the study Exclusion Criteria: * Signs of severe malaria (adapted from WHO criteria) * Patients not fulfilling criteria for severe malaria but with another indication for parenteral antimalarial treatment at the discretion of the treating physician * Haematocrit \<15% at screening (For Gambia, Rwanda sites only: For subjects ≥12 years - Haematocrit \<20% at screening) * Subjects who have received artemisinin or a derivative within the previous 7 days OR lumefantrine or amodiaquine within the previous 14 days OR mefloquine or piperaquine within the previous 30 days * In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 14 days. * Acute illness other than malaria requiring systemic treatment * Severe acute malnutrition (in Niger only - only those patients with Severe Acute Malnutrition and complications requiring inpatient nutritional treatment will be excluded) * Known HIV infection * Known tuberculosis infection * For females: post-menarche (For Gambia, Rwanda sites only: females who are pregnant, trying to get pregnant or are lactating) * History of allergy or known contraindication to any of the study drugs, including neuropsychiatric disorders and epilepsy * Previous splenectomy * Enrolment in DeTACT in the previous 3 months * Participation in another interventional study in the previous 3 months

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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

  • Centre National de Formation et de Recherche en Santé Rurale de Mafèrinyah

    Conakry, B.P. 2649, Guinea

  • Centre for Malaria and Other Tropical Diseases (CEMTROD)

    Ilorin, Kwara State, 1459, Nigeria

  • College of Medicine and Health Sciences, University of Rwanda

    Kigali, Rwanda

  • Epicentre Niger

    Niamey, BP: 13 330, Niger

  • Institut des Sciences et Techniques (INSTech)

    Bobo-Dioulasso, Burkina Faso

  • Kinshasa School of Public Health

    Kinshasa, BP 11850 Kin, Democratic Republic of the Congo

  • MRC Unit The Gambia at LSHTM

    Fajara, City of Banjul, 273, The Gambia

  • National Institute For Medical Research (NIMR), Tanga Medical Research Centre

    Tanga, Tanzania