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Breastfeeding women finally included in TB drug research

NCT ID NCT07069582

Knowledge-focused Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how five common tuberculosis drugs move into breast milk after a single dose. Sixty healthy breastfeeding women in Indonesia will each receive one drug, and researchers will measure drug levels in their blood and milk. The goal is to gather safety data so that breastfeeding women can be included in future TB prevention trials.

What this could mean

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

Active substance
Rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline
What this could lead to
If successful, this study could help include breastfeeding women in future TB prevention trials, ensuring safer dosing guidelines for mothers and infants.
What could go wrong
This is an early-phase, single-dose study in healthy volunteers, not patients. Results may not apply to women with TB or to repeated dosing, and drug levels in milk may vary widely.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

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

Oct 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.

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: Participants may enter the study if all of the following apply: 1. Healthy breastfeeding women aged 18 years or older, with a minimum of 3 months and a maximum of 24 months after delivery of a healthy baby, and are not currently diagnosed with either TB infection or TB disease. 2. Have a body weight between 25 and 100 kg. 3. Provide written informed consent. Exclusion Criteria: Participants may not enter the study if any of the following criteria apply: 1. Grade 3-4 abnormalities on baseline blood chemistry tests, including serum alanine aminotransferase (ALT), creatinine, or blood glucose. 2. Grade 3-4 abnormalities on baseline hematological tests, including white blood count, platelets, or hemoglobin. 3. Contraindications or history of hypersensitivity/intolerance to rifampicin, isoniazid, levofloxacin, rifapentine, or bedaquiline. 4. Taking concomitant medications for TB disease, TB infection, diabetes mellitus, hypertension, HIV, cardiac disease or any other chronic diseases. 5. Having a breastfed infant who was diagnosed with TB infection or TB disease and is currently on treatment. 6. Pregnancy 7. Have an active, acute illness at the time of study enrolment.

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Conditions

The condition(s) this trial relates to.

Breast Feeding latent tuberculosis infection

As listed by the trial registrant

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

Breastfeeding Healthy volunteer Tuberculosis infection

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

  • Universitas Padjadjaran, Klinik Penelitian Tuberculosis (TB Research Clinic)

    Bandung, West Java, 40161, Indonesia

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