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Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis:BLMZ Chinese Cohort
Sponsor: Beijing Chest Hospital
Summary
The goal of this clinical trial is to learn if the all-oral, shorter-course BLMZ regimen can treat Rifampicin-Resistant Tuberculosis (RR-TB) in Chinese participants aged 12 years and older. The main questions it aims to answer are: What is the proportion of participants with a favorable outcome at 18 months after starting the BLMZ regimen? What is the safety profile of the BLMZ regimen, as measured by the incidence of Grade 3 or higher adverse events and serious adverse events during the treatment period? This is a single-arm study, so there is no comparison group. Researchers will compare the study results to historical data to see if the BLMZ regimen shows sufficient efficacy and safety in the Chinese population. Participants will: Undergo screening tests to confirm eligibility, including tests for TB bacteria and drug resistance. Receive the BLMZ regimen (Bedaquiline, Linezolid, Moxifloxacin/Levofloxacin, and Pyrazinamide) orally for 9 months. Attend regular clinic visits for safety assessments, medication refills, and tests (e.g., sputum tests, blood tests, ECG, CT scans) during the 9-month treatment period and then every 3 months during a 15-month post-treatment follow-up period until 24 months after starting the treatment.
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-12-01
Completion Date
2028-08-31
Last Updated
2025-12-08
Healthy Volunteers
No
Conditions
Interventions
BLMZ
The regimen is composed of the following four drugs, with doses adjusted by body weight: Bedaquiline (BDQ): * Weeks 1-2: 400 mg (two 200 mg tablets) orally, once daily. * Weeks 3 to Month 9: 200 mg orally, three times per week (with at least 48 hours between doses). Linezolid (LZD): * Months 1-4: 600 mg orally, once daily. * Months 5-9: Dose reduced to 300 mg orally, once daily (or an intermittent dosing strategy) for the remainder of treatment. Earlier dose adjustment is permitted in cases of drug intolerance or related adverse events. Moxifloxacin (MFX): \- 400 mg orally, once daily throughout the 9-month treatment. Pyrazinamide (PZA): \- Administered orally, once daily at a weight-based dose: 750 mg for participants weighing 30-34.9 kg 1000 mg for participants weighing 35-49.9 kg 1500 mg for participants weighing ≥50 kg
Locations (3)
The Third People's Hospital in Aksou
Aksu, Xinjiang, China
Hetian Prefecture Infectious Diseases Hospital
Hetian, Xinjiang, China
Center of Disease Prevention and Control in Kashi Area
Kashgar, Xinjiang, China