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Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women

Study acronym: PRiMe
StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Oct 1, 2025 to Apr 1, 2026v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07069582
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: Faculty of Medicine Universitas Padjadjaran
Conditions
(from sponsor)
Tuberculosis Infection, Healthy Volunteer, Breastfeeding
Related terms Breast Feeding, Latent Tuberculosis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov