NCT06476210

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Beijing Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	BDL regimen	Drug:bedaquiline 100mg tablets Other Names: Bdq TMC-207 bedaquiline 400 mg once daily for 2 weeks then 200mg 3 times per week Drug:delamanid 50mg tablets Other Names: Dlm OPC-67683 delamanid 100mg 2 times daily Drug:linezolid Scored 600mg tablets Other Names: Lzd linezolid 600mg once daily

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2024-06-26
• Last updated: 2024-06-26

Locations

7 sites across 1 country: China