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New study tracks TB drugs in breastmilk to protect infants

NCT ID NCT05840809

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looks at how tuberculosis (TB) medications travel through a mother's body, into her breastmilk, and to her nursing baby. Researchers will take blood and milk samples from 20 mothers and small blood samples from their infants at several time points after a dose. The goal is to understand drug levels so doctors can better treat TB in breastfeeding women while keeping babies safe.

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

20 people

The number who actually took part.

Started

Jan 2022

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

Breastfeeding women, including those living with HIV, treated for TB will be recruited prospectively from Infectious Diseases clinic (IDI) and IDI Kampala City Council Authority (KCCA) affiliated clinics. The clinics treat pregnant and breast-feeding women infected with TB. We anticipate that 80% of women will be living with HIV. Drug-drug interactions between antiretroviral therapy (ART) and TB drugs could affect the exposure of TB drugs. Data on concomitant medication will be recorded and included as a covariate in the pharmacokinetic analysis. In accordance with national protocol, the infants of mothers diagnosed with TB treatment will receive isoniazid preventive therapy for six months (the duration of the mothers' TB treatment).

Ages

18 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 4. Receiving treatment for drug sensitive TB 5. Pregnant or 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

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Conditions

The condition(s) this trial relates to.

active tuberculosis Breast Feeding tuberculosis

As listed by the trial registrant

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

Breastfeeding Tuberculosis Tuberculosis active

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.