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)
- Conditions
- Pulmonary Tuberculosis
- Interventions
- Drug: BDL regimen
- Registration Number
- NCT06476210
- Lead Sponsor
- Beijing Chest Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BDL interventionv group BDL regimen -
- Primary Outcome Measures
Name Time Method The efficacy outcome at the end of treatment 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 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 Baseline (within 9 days before treatment initiation), weeks 1-16, 20 and 26 during the intervention
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (7)
Anhui Chest Hospital
🇨🇳Hefei, Anhui, China
Wuhan Institute for Tuberculosis Control
🇨🇳Wuhan, Hubei, China
Beijing Chest Hospital
🇨🇳Beijing, Beijing, China
Public Health Clinical Meadical Center of Chengdu
🇨🇳Chengdu, Sichuan, China
Hunan Chest Hospital
🇨🇳Changsha, Hunan, China
Changsha Central Hospital
🇨🇳Changsha, Hunan, China
Shandong Public Health Clinical Center
🇨🇳Jinan, Shandong, China