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.
1.A patient with multi-drug resistant/rifampicin-resistant pulmonary tuberculosis (MDR/RR-TB) with recent laboratory evidence (culture or molecular testing) within the last two months
2.Age 18 years above
3.No prior use of neither bedaquiline, delamanid, linezolid, or use for less than 4 weeks
4.Positive culture result for mycobacterial at baseline(regardless smear positive or negative). No anti-tuberculosis treatment received within one month.
1.According to DMID, peripheral neuropathy is classified as grade 3 or 4. Alternatively, participants with grade 1 or 2 neuropathy, which the investigator believes may progress/worsen during the study
2.Elevation of ALT or AST ≥3 times the upper limit of normal, or elevation of total bilirubin and direct bilirubin ≥2 times the upper limit of normal
3.Pregnant women or those who intent to pregnant during treatment
4.Participants who have participated in other drug trials in the past three months
Beijing Chest Hospital
Lead sponsor
Chengdu Public Health Clinical Center
Collaborator
Wuhan Institute for Tuberculosis Control
Collaborator
Changsha Central Hospital
Collaborator
Anhui Chest Hospital
Collaborator
Hunan Chest Hospital
Collaborator
Shandong Public Health Clinical Center
Collaborator