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.
Beijing Chest Hospital
Lead sponsor
National Medical Center for Infectious Diseases
Collaborator
Huashan Hospital
Collaborator