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)
NCT Number: NCT06476210
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Pulmonary Tuberculosis
Interventions: DRUG: BDL regimen
Sponsor: Beijing Chest Hospital
Collaborators: Public Health Clinical Medical Center of Chengdu|Wuhan Institute for Tuberculosis Control|Changsha Central Hospital|Anhui Chest Hospital|Hunan Chest Hospital|Shandong Public Health Clinical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 45
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2026-06
Locations: Anhui Chest Hospital, Hefei, Anhui, 230000, China|Beijing Chest Hospital, Beijing, Beijing, 101149, China|Wuhan Institute for Tuberculosis Control, Wuhan, Hubei, 430000, China|Changsha Central Hospital, Changsha, Hunan, 410000, China|Hunan Chest Hospital, Changsha, Hunan, 410000, China|Shandong Public Health Clinical Center, Jinan, Shandong, 250000, China|Public Health Clinical Meadical Center of Chengdu, Chengdu, Sichuan, 610000, China

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.

Primary Outcome Measures: 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, 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, Baseline (within 9 days before treatment initiation), weeks 1-16, 20 and 26 during the intervention
Secondary Outcome Measures: Incidence of patients have bacterial recurrence within 12 months after treatment completion, 3,6,9,12 months after the intervention|Time for sputum culture conversion to stable negativity during treatment, 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, during the intervention