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New study Fine-Tunes malaria drug dosing for kids

NCT ID NCT05750459

Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study looked at how the malaria drug artesunate works in 90 Ugandan children aged 6 months to 14 years with severe malaria. Researchers measured drug levels in the blood and tracked vital signs like temperature and blood pressure to see how the body responds. The goal was to better understand the right dose for children to improve treatment.

What this could mean

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

Active substance
artesunate
What this could lead to
If successful, this study could help doctors give the right dose of IV artesunate to children with severe malaria, potentially improving recovery.
What could go wrong
This is a small, single-site study that measured drug levels and body responses, not whether the drug works better than other treatments. Results may not apply to all children.

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

90 people

The number who actually took part.

Started

Nov 2023

Finished

Apr 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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 14 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. Children ages 6 months-14 years at the time of severe malaria diagnosis, inclusive 2. Meet the case definition for severe malaria, per WHO standardized guidelines 3. Parent/guardian willing to provide informed consent 4. Assent for children between 8 and 14 years who are conscious and otherwise able to provide assent, inclusive Exclusion Criteria: 1\. Receipt of \> 24 hours of artemisinin therapy

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Conditions

The condition(s) this trial relates to.

malaria Plasmodium falciparum malaria

As listed by the trial registrant

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

Plasmodium falciparum infection

Contacts and locations

Locations

  • Makerere University-Infectious Diseases Institute

    Kampala, Uganda

More trials for these conditions

Other studies related to the condition(s) this trial covers.