Recruiting soon

PRiMeAntituberculosis Drug Exposure in Breastfeeding Women

What is being tested

Standard dose rifampicin

+ High dose rifampicin

+ Standard dose isoniazid

Drug

Who is being recruted

Latent Infection+9

+ Actinomycetales Infections

+ Bacterial Infections and Mycoses

Over 18 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: April 2026

See protocol details

Summary

Principal SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Study ContactDick Menzies, MDMore contacts

Last updated: February 11, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on understanding how certain tuberculosis (TB) medications affect breastfeeding women and their infants. Pregnant and breastfeeding women often miss out on new TB treatments because of safety concerns. This research aims to gather important information about how drugs like rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline behave in the body and how much of these drugs pass into breast milk. The goal is to help ensure these women can safely participate in future clinical trials for shorter and more effective TB prevention treatments, which could significantly improve their access to modern care. Participants in this study are healthy breastfeeding women from health care centers in Bandung, Indonesia. They will receive a single dose of one of the TB medications by mouth. The study measures how much of the drug is present in the women’s blood and breast milk over 24 hours, particularly looking at the highest concentration reached and the overall exposure. This helps estimate how much of the drug could be passed to the infant. Other measurements include how quickly the drug reaches its peak concentration and how fast it is eliminated from the body. The study is designed to provide a detailed understanding of the drug's behavior to ensure safety for both mothers and their breastfeeding children.

Official TitlePlasma and Breastmilk Exposures to Antituberculosis Drugs in Breastfeeding Women: an Open-label, Randomized, Six-arm, Single-dose, Pharmacokinetic Study

NCT07069582

Principal SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Study ContactDick Menzies, MDMore contacts

Last updated: February 11, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Latent InfectionActinomycetales InfectionsBacterial Infections and MycosesBacterial InfectionsBehaviorBreast FeedingFeeding BehaviorInfectionsMycobacterium InfectionsTuberculosisGram-Positive Bacterial InfectionsLatent Tuberculosis

Criteria

3 inclusion criteria required to participate

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.

Have a body weight between 25 and 100 kg.

Provide written informed consent.

7 exclusion criteria prevent from participating

Grade 3-4 abnormalities on baseline blood chemistry tests, including serum alanine aminotransferase (ALT), creatinine, or blood glucose.

Grade 3-4 abnormalities on baseline hematological tests, including white blood count, platelets, or hemoglobin.

Contraindications or history of hypersensitivity/intolerance to rifampicin, isoniazid, levofloxacin, rifapentine, or bedaquiline.

Taking concomitant medications for TB disease, TB infection, diabetes mellitus, hypertension, HIV, cardiac disease or any other chronic diseases.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Single-dose rifampicin at 10 mg/kg body weight

Group II

Experimental

Single-dose rifampicin at 20 mg/kg body weight

Group III

Experimental

Single-dose isoniazid at 5 mg/kg body weight

Group IV

Experimental

Single-dose levofloxacin at 10-15 mg/kg body weight

Group 5

Experimental

Single-dose rifapentine at 10 mg/kg body weight

Group 6

Experimental

Single-dose bedaquiline at 400 mg

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Universitas Padjadjaran, Klinik Penelitian Tuberculosis (TB Research Clinic)

Bandung, IndonesiaOpen Universitas Padjadjaran, Klinik Penelitian Tuberculosis (TB Research Clinic) in Google Maps

Recruiting soonOne Study Center