Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07268664 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis:BLMZ Chinese Cohort

Study acronym: INSPIRE-BLMZ
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07268664
Lead Sponsor Beijing Chest Hospital
Collaborators: National Medical Center for Infectious Diseases, Huashan Hospital
Conditions
(from sponsor)
Rifampicin Resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Drug-resistant Tuberculosis
Related terms Tuberculosis, Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov