The Safety and Efficacy of BDL(Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis (MDR-TB) or Rifampicin-Resistant Tuberculosis (RR-TB)

• Status: RECRUITING
• Trial end date: 2026-06-01

Summary

The goal of this investigator initiated trial (IIT) is to learn if a 6-9months BDL regimen (bedaquiline plus delamanid plus linezolid）works to treat adults with multi-drug resistant tuberculosis or rifampicin-resistant pulmonary tuberculosis, in the context of Pretomanid not available in China. It will also learn about the safety of BDL regimen.

The main questions it aims to answer are:

1. What is the percentage of participants with favorable treatment outcome at the end of treatment?

2. What are the frequency and degree of AE and SAE associated with BDL regimen?

Participants will take Bedaquiline +Delamanid+ Linezolid for 6 months, option for 9 months for subjects who remain culture positive at month 4 to 6. Safety and efficacy data will be monitored and collected during treatment. A 12 month follow-up will be conducted after treatment completion.

• Phase: PHASE4

Details

• Lead Sponsor: Beijing Chest Hospital
• Collaborators: Anhui Chest Hospital; Changsha Central Hospital; Hunan Chest Hospital; Public Health Clinical Medical Center of Chengdu; Shandong Public Health Clinical Center; Wuhan Institute for Tuberculosis Control