Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant TuberculosisBLMZ Chinese Cohort

• Status: NOT_YET_RECRUITING
• Trial end date: 2028-08-31

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.

• Phase: PHASE3

Details

• Lead Sponsor: Beijing Chest Hospital
• Collaborators: Huashan Hospital; National Medical Center for Infectious Diseases