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Two-Drug malaria punch targets faster cure in kids

NCT ID NCT07811908

Cure Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing whether a combination of cipargamin and KLU156 (ganaplacide plus lumefantrine) can cure uncomplicated Plasmodium falciparum malaria in children aged 2 to under 12. The trial compares this oral regimen with standard Coartem treatment. The main goal is to see if children remain parasite-free 29 days after treatment, with secondary checks on how quickly the drugs clear the parasite from the blood.

What this could mean

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

Active substance
cipargamin given together with ganaplacide and lumefantrine
What this could lead to
If the combination works, it could offer a faster, single-course cure for children with uncomplicated malaria and help counter drug resistance.
What could go wrong
This is a mid-stage trial in a small group of children, so the combination may not clear parasites as well as standard care or may cause side effects that only larger studies reveal.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

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

Started

Feb 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 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: 1. Male and female participants 2 to \<12 years of age at screening. 2. Participants must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 1,000 to 150,000 asexual parasite count/μl of blood for P. falciparum. 3. Participants must weigh at least 10 kg at screening. Exclusion Criteria: 1. Participants with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening 2. Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level \< 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening 3. Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening: * AST/ALT \> 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin * AST/ALT \> 1.5 and ≤ 2 x ULN and total bilirubin is \> ULN * Total bilirubin \> 2 x ULN, regardless of the level of AST/ALT 4. Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening. 5. History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as: * Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker * History of familial long QT syndrome or known family history of Torsades de Pointe. * Resting heart rate (physical exam or 12 lead ECG) \< 50 bpm Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Plasmodium falciparum malaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Uncomplicated plasmodium falciparum malaria

How to take part

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

  1. The places running it

    13 sites in 7 countries. 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

  • Novartis Investigative Site

    RECRUITING

    Banfora, Burkina Faso

  • Novartis Investigative Site

    NOT_YET_RECRUITING

    Nanoro, BP 18, Burkina Faso

  • Novartis Investigative Site

    RECRUITING

    Abidjan, 13BP972, Côte d’Ivoire

  • Novartis Investigative Site

    RECRUITING

    Azaguié, BP 173, Côte d’Ivoire

  • Novartis Investigative Site

    NOT_YET_RECRUITING

    Lambaréné, BP 242, Gabon

  • Novartis Investigative Site

    NOT_YET_RECRUITING

    Libreville, BP 1437, Gabon

  • Novartis Investigative Site

    NOT_YET_RECRUITING

    Kintampo, 92037, Ghana

  • Novartis Investigative Site

    NOT_YET_RECRUITING

    Navrongo, VWJ6+8WF, Ghana

  • Novartis Investigative Site

    NOT_YET_RECRUITING

    Ahero, 40100, Kenya

  • Novartis Investigative Site

    NOT_YET_RECRUITING

    Kisumu, 40100, Kenya

  • Novartis Investigative Site

    RECRUITING

    Kigali, BP 4560, Rwanda

  • Novartis Investigative Site

    NOT_YET_RECRUITING

    Kampala, 101, Uganda

  • Novartis Investigative Site

    NOT_YET_RECRUITING

    Tororo, 10102, Uganda

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