Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women

Summary

This study is a sub-study of the SSTARLET trial (NCT06498414). The overall aim is to assess the pharmacokinetic profiles after taking a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in breastfeeding women and the excretion of these drugs in breast milk, with the hope of including breastfeeding women in future clinical trials of TPT, including expanding the inclusion criteria of the SSTARLET trial. In this study, healthy breastfeeding women who fulfill the eligibility criteria will be enrolled from several primary health care centers in Bandung, which will be referred to the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia. Ten participants will be randomized to each of the following six study arms:

* Arm A: Single-dose rifampicin at 10 mg/kg body weight (RIF10).
* Arm B: Single-dose rifampicin at 20 mg/kg body weight (RIF20).
* Arm C: Single-dose isoniazid at 5 mg/kg body weight (INH5).
* Arm D: Single-dose levofloxacin at 10-15 mg/kg body weight (LFX10-15).
* Arm E: Single-dose rifapentine at 10 mg/kg body weight (RPT10).
* Arm F: Single-dose bedaquiline at 400 mg (BDQ400).

Conditions

• Tuberculosis Infection
• Healthy Volunteer
• Breastfeeding

Interventions

DRUG

Standard dose rifampicin

Single-dose rifampicin at 10 mg/kg body weight

DRUG

High dose rifampicin

Single-dose rifampicin at 20 mg/kg body weight

DRUG

Standard dose isoniazid

Single-dose isoniazid at 5 mg/kg body weight

DRUG

Standard dose levofloxacin

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

DRUG

Standard dose rifapentine

Single-dose rifapentine at 10 mg/kg body weight

DRUG

Standard dose bedaquiline

Single-dose bedaquiline at 400 mg

Sponsors & Collaborators

• Faculty of Medicine Universitas Padjadjaran

  collaborator UNKNOWN

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Dick Menzies, MD · Research Institute of the McGill University Health Centre, Montreal, Canada

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2026-10-31

Completion

2026-10-31

Countries

• Indonesia

Study Locations