Overview

BPaL Regimen in FQ Resistant MDR-TB

Status:
Not yet recruiting
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to analyze the efficacy of a new regimen using Bedaquiline, Pretomanid, and Linezolid for 26 weeks (6 months) for the treatment of FQ-resistant MDR-TB through the clinical trial. The recently completed Zenix trial observed that lower doses and/or shorter durations of linezolid than 1200mg for 6 months appear to have high efficacy and improved safety. Therefore, the primary objective of this study is to analyze the effectiveness and safety of the BPaL regimen including modified dosing of linezolid for the patients with fluoroquinolone-resistant MDR-TB.
Phase:
Phase 4
Details
Lead Sponsor:
Asan Medical Center
Collaborators:
Chonnam National University Hospital
Funded by Korea Disease Control and Prevent Agency
International Tuberculosis Research Center
Investigational drug(Pretomanid) supported by Viatris Pharmaceutical
Masan National Tuberculosis Hospital
Pusan National University Hospital
Samsung Medical Center
Seoul National University Hospital
Severance Hospital