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RECRUITING
NCT06476210
PHASE4

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)

Sponsor: Beijing Chest Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2024-06

Completion Date

2026-06

Last Updated

2024-06-26

Healthy Volunteers

No

Interventions

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

Locations (7)

Anhui Chest Hospital

Hefei, Anhui, China

Beijing Chest Hospital

Beijing, Beijing Municipality, China

Wuhan Institute for Tuberculosis Control

Wuhan, Hubei, China

Changsha Central Hospital

Changsha, Hunan, China

Hunan Chest Hospital

Changsha, Hunan, China

Shandong Public Health Clinical Center

Jinan, Shandong, China

Public Health Clinical Meadical Center of Chengdu

Chengdu, Sichuan, China