Pharmacokinetics of Drugs Used to Treat Drug Sensitive Tuberculosis in Breastfeeding Mother-infant Pairs

Pregnant or lactating women requiring treatment for drug sensitive-TB will be identified and invited for sampling. If they are pregnant when identified, they will be invited for sampling after delivery. Plasma and breastmilk samples will be obtained pre-dose and at 2, 4, 6, and 8 hours post-dose. If logistics permit (for example living close to the research unit), the participant will be invited for a further sample at 24 hours post-dose. A heelprick sample will also be obtained from their breastfed infants at maternal trough (prior to maternal dose) and at a random timepoint (once per infant) over the 8-hour pharmacokinetic sampling visit in order to characterize concentrations of these drugs over an 8-hour dosing interval. Total concentrations of plasma and breastmilk Isoniazid, Rifampicin, Pyrazinamide and Ethambutol will be determined. If a participant has her first pharmacokinetic profile in the intensive phase of TB treatment (whilst on all four of isoniazid, rifampicin, pyrazinamide and ethambutol), she will be invited for a subsequent sampling day with the same time points when she is on the continuation phase of therapy (rifampicin and isoniazid).

NCT Number	NCT05840809
Lead Sponsor	University of Liverpool Collaborators: Makerere University
Conditions	Tuberculosis Active, Breastfeeding, Tuberculosis
Enrollment	20 participants
Start Date	2022-01-20
Primary Completion	2024-12-20 (estimated)
Study Completion	2026-12-06 (estimated)
Updated on ClinicalTrials.gov	2026-05-07