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New study aims to safely treat breastfeeding moms for malaria

NCT ID NCT07060404

Disease control Sponsor: Curtin University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how much of the malaria drugs primaquine and tafenoquine pass to babies through breast milk. It involves 60 breastfeeding mothers in Papua New Guinea who recently gave birth. The goal is to find a safe way to treat and prevent relapses of vivax malaria in new mothers without harming their infants.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 60 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 2027

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

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. ≥18 years of age 2. Both mother and infant have G6PD activity \>70% (normal activity; SD Biosensor) 3. They have no significant co-morbidity 4. Delivered a live singleton baby within past 48-hours 5. Rapid diagnostic test negative for malaria 6. No history of hypersensitivity to 8-aminoquinoline drugs 7. Plan to exclusively breastfeed for at least two months 8. History of vivax malaria (as per health book) 9. They can attend follow-up assessments for the duration of the study Exclusion Criteria: 1. Either mother/infant have G6PD activity \<70% (SD Biosensor) 2. Either mother/infant have significant co-morbidity 3. Mother did not deliver a live singleton within past 48-hours 4. Mother/infant are rapid diagnostic test positive for malaria 5. Mother has a history of hypersensitivity to 8-aminoquinoline drugs 6. Mother does not plan to exclusively breastfeed for at least two months 7. Mother does not have a history of vivax malaria (as per health book) 8. Cannot or are not willing to attend follow-up assessments for the duration of the study

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Conditions

The condition(s) this trial relates to.

Breast Feeding Plasmodium vivax malaria

As listed by the trial registrant

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

Drug pharmacokinetics in healthy volunteers

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

  • Alexishafen Health Centre

    Madang, Madang Province, MP511, Papua New Guinea