Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how certain tuberculosis (TB) medicines behave in the bodies of breastfeeding women and how much of these medicines pass into breast milk. The goal is to better understand the safety and effects of these drugs when given as a single dose, which can help include breastfeeding women in future TB prevention studies. The medicines being tested are rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline—common drugs used to treat or prevent TB.

Women who may join this study need to be healthy, breastfeeding, at least 18 years old, and between 3 months and 2 years after giving birth. They should not have TB or other serious health problems and must agree to take part by signing a consent form. If chosen, participants will receive just one dose of one of the TB medicines and will be monitored to see how the drug moves through their body and breast milk. This research will take place in Bandung, Indonesia, and is not yet recruiting participants. The information collected will help make sure future TB treatments are safe for breastfeeding mothers and their babies.

Gender

FEMALE

Eligibility criteria

• 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.