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.
The participant (and their guardian if the participant lacks civil capacity) voluntarily signs the informed consent form (ICF) prior to enrollment.
The participant (and their guardian) indicates willingness to complete all steps and intervention periods of the study.
Male or female, aged ≥12 years, with a body weight ≥30 kilograms (kg).
Bacteriologically confirmed pulmonary tuberculosis, with molecular or phenotypic drug susceptibility testing (DST) results within the last 3 months confirming Rifampicin resistance and susceptibility to at least one of Moxifloxacin (MFX) or Levofloxacin (LFX).
Previous treatment with any of the drugs Bedaquiline (BDQ) or Linezolid (LZD) for more than 30 days.
Concurrent hematogenous disseminated pulmonary tuberculosis or severe extrapulmonary tuberculosis as determined by the investigator.
Current use of medications prohibited by the study protocol, and the investigator judges that the priority of continuing said medication for patient benefit outweighs participation in this study.
Known history of hypersensitivity to any drug in the protocol.
Single group
BLMZ
DrugThe 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
The proportion of participants with favorable outcome
Favorable Outcome: A participant is considered to have a favorable outcome if they do not meet any criteria for an unfavorable outcome, and they meet the following key criterion: two consecutive negative sputum cultures, with the final culture obtained between 16 and 18 months after treatment initiation. Unfavorable Outcome: An outcome is classified as unfavorable if any of the following occur: * Treatment failure (change of regimen). * Extended treatment beyond the protocol-defined period. * Bacteriological relapse or failure (positive culture at the end of the study period). * Death from any cause. * Loss to follow-up.
The proportion of participants with favorable outcome
The proportion of participants with favorable outcome
The proportion of participants with sputum conversion
Time to sputum conversion
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Beijing Chest Hospital
Lead sponsor
National Medical Center for Infectious Diseases
Collaborator
Huashan Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
