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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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
Anhui Chest Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGBeijing Chest Hospital
Beijing, Beijing Municipality, China
RECRUITINGWuhan Institute for Tuberculosis Control
Wuhan, Hubei, China
NOT_YET_RECRUITINGChangsha Central Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGHunan Chest Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGShandong Public Health Clinical Center
Jinan, Shandong, China
NOT_YET_RECRUITINGPublic Health Clinical Meadical Center of Chengdu
Chengdu, Sichuan, China
NOT_YET_RECRUITINGThe 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
Time frame: Baseline (within 9 days before treatment initiation), weeks 1, 2, 4, 6, 8 of treatment, thereafter every 4 weeks until week 26(or 39 weeks for patients require prolonged treatment) during the intervention
Frequency of any adverse events (AEs) and serious adverse events (SAEs) occurring during the treatment period
Time frame: Baseline (within 9 days before treatment initiation), weeks 1-16, 20 and 26 during the intervention
Incidence of patients have bacterial recurrence within 12 months after treatment completion
Time frame: 3,6,9,12 months after the intervention
Time for sputum culture conversion to stable negativity during treatment
Time frame: 3,6,9,12 months after the intervention
Proportion of patients who discontinued treatment due to adverse reactions or permanently unable to take the medication
Time frame: during the intervention
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