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

NCT07268664 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-08

No results posted yet for this study

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.

Conditions

  • Rifampicin Resistant Tuberculosis
  • Pulmonary Tuberculosis
  • Tuberculosis
  • Drug-resistant Tuberculosis

Interventions

DRUG

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

Sponsors & Collaborators

  • National Medical Center for Infectious Diseases

    collaborator UNKNOWN

  • Huashan Hospital

    collaborator OTHER

  • Beijing Chest Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-05-31
Completion
2028-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07268664 on ClinicalTrials.gov