PRIME is a sub-study of the SSTARLET trial. 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).
- 鈦燗rm B: Single-dose rifampicin at 20 mg/kg body weight (RIF20).
- 鈦燗rm C: Single-dose isoniazid at 5 mg/kg body weight (INH5).
- 鈦燗rm D: Single-dose levofloxacin at 10-15 mg/kg body weight (LFX10-15).
- 鈦燗rm E: Single-dose rifapentine at 10 mg/kg body weight (RPT10).
- 鈦燗rm F: Single-dose bedaquiline at 400 mg (BDQ400).
This study is co-led by Prof. Dick Menzies from MITBC and Prof. Rovina Ruslami from Universitas Padjadjaran (UNPAD), Bandung, Indonesia. Co-investigators include Dr. Fajri Gafar (MITBC) and Dr. Vycke Yunivita (UNPAD). Further details of the study are available from ClinicalTrials.gov (NCT07069582).
