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New triple drug combo could beat malaria resistance

NCT ID NCT05951595

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new triple-drug combination (artemether-lumefantrine-amodiaquine) against standard two-drug treatments for uncomplicated malaria. About 1680 people with malaria will receive one of the treatments and be monitored for 42 days. The goal is to see if the triple therapy works as well or better, especially against drug-resistant malaria.

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

About 1,680 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

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 and older

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 (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 monoinfection * Asexual P. falciparum parasitaemia: 1,000/µL to 250,000/µL determined on a peripheral blood film * Written informed consent by the participant, or by the parent/guardian in case of children lower than the age of consent, and assent if required (per local regulations) * Willingness and ability of the participants 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 other indication(s) for parenteral antimalarial treatment at the discretion of the treating physician * Haemoglobin \<7 g/dL at screening * Participants who have received artemisinin or a derivative within the previous 7 days OR lumefantrine or amodiaquine within the previous 14 days * In applicable countries: use of seasonal malaria chemoprophylaxis (SMC) within the last 30 days * Acute illness other than malaria requiring systemic treatment * Severe acute malnutrition * Known HIV, tuberculosis, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or other severe infection * For women of child-bearing age: pregnant, trying to get pregnant or lactating * History of allergy or known contraindication to any of the study drugs, including neuropsychiatric disorders and epilepsy * Previous splenectomy * Participation in the previous 3 months and/or ongoing follow-up for an interventional study (including FD-TACT)

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ruhuha Health Centre

    RECRUITING

    Ruhuha, Eastern Province, Rwanda

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