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
Single group
BDL regimen
DrugDrug: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
The efficacy outcome at the end of treatment
The efficacy outcome of treatment: bacteriological positive patients completed the prescribed treatment course, demonstrating bacteriological response without evidence of treatment failure Notes: bacteriological outcome response:bacterial culture conversion to negative and no recurrence of positivity thereafter Bacteriological conversion refers to confirmed tuberculosis patients having two or more consecutive negative sputum culture results, with at least a 7-day interval between each Recurrence of positivity refers to two or more consecutive sputum cultures were positive after bacteriological conversion, with at least a 7-day interval between each
Frequency of any adverse events (AEs) and serious adverse events (SAEs) occurring during the treatment period
Incidence of patients have bacterial recurrence within 12 months after treatment completion
Time for sputum culture conversion to stable negativity during treatment
Proportion of patients who discontinued treatment due to adverse reactions or permanently unable to take the medication
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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
