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Breastfeeding moms with malaria: do drugs reach baby?

NCT ID NCT05676645

Knowledge-focused Sponsor: University of Liverpool 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tracks how the malaria drug artemether-lumefantrine passes from a breastfeeding mother into her breastmilk and then into her nursing infant. Researchers will take blood and milk samples from 30 mother-infant pairs in Uganda over two weeks. The goal is to understand drug exposure in infants, which could lead to better dosing guidelines for breastfeeding women.

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
What this could lead to
If successful, this study could provide data to help doctors choose safe and effective malaria treatments for breastfeeding women and their babies.
What could go wrong
This is a small observational study (30 pairs) that only measures drug levels, not health outcomes. Results may not apply to other malaria drugs or regions.

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.

Participants

30 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Dec 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.

Who is studied

Ugandan breastfeeding women requiring treatment for uncomplicated malaria

Ages

14 years and older

Sex

Female participants only

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. A personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study. 2. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Woman is aged 18 years or older, and mothers between the age of 14-17, who are considered emancipated minors. 4. Receiving treatment for uncomplicated malaria 5. Breastfeeding at enrolment Exclusion Criteria: 1. Severe maternal or infant illness which in the opinion of the patient's clinician would interfere with her participation in the study 2. Breastfed infant is aged over 12 months 3. Partner objection to participate in the study 4. Maternal objection to infant participation

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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.

Malaria falciparum

Contacts and locations

Locations

  • Infectious Diseases Institute

    Kampala, Kampala, 22418, Uganda

More trials for these conditions

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