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New hope for the tiniest malaria patients: a safer treatment for infants under 5 kg

NCT ID NCT07713602

Disease control 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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests a specially formulated dispersible tablet, Coartem Baby, in infants weighing between 2 and 5 kg who have uncomplicated malaria. The goal is to see if the drug is safe and effectively clears symptoms like fever and chills. Twenty infants will receive the standard three-day treatment, and researchers will monitor for side effects and recovery.

What this could mean

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

Active substance
Coartem Baby (artemether/lumefantrine) dispersible tablets
What this could lead to
If successful, this could provide a safe and effective treatment option for the smallest infants with malaria, a group often excluded from studies.
What could go wrong
This is a small, early-phase study with only 20 participants and no comparison group, so results may not apply broadly. Side effects are possible, as with any medication.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 20 people

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

Expected to start

Jun 2027

An estimate. Start dates often move.

Expected to finish

May 2028

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

0 days to 12 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

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

Key Inclusion Criteria: * Male or female neonates/infants * Body weight ≥ 2 kg to \< 5kg * Confirmed diagnosis of uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum malaria by RDT or microscopy. * Eligible to receive Coartem® Baby dispersible tablets as per approved label Key Exclusion Criteria: Participants with Coartem® Baby contraindications as per approved label. * Known hypersensitivity to artemether, lumefantrine or to any of the excipients of Coartem® Baby. * Patients with severe malaria according to WHO definition (See Appendix 3). * Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease. * Patients taking drugs that are known to prolong the QTc interval * Any additional contraindications as per the approved label in the country

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Conditions

The condition(s) this trial relates to.

malaria mixed malaria Plasmodium falciparum malaria

As listed by the trial registrant

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

Malaria

How to take part

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  1. 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 ↗

  2. 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.

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