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

NCT07268664 | Not Yet Recruiting Phase 3

• 1 other identifier: BJCH-202509
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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

Tuberculosis; Drug-resistant Tuberculosis; Rifampicin Resistant Tuberculosis; Pulmonary Tuberculosis

Keywords

drug-resistant tuberculosis; all-oral regimen; 9 month regimen; tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months after treatment initiation

Secondary Outcomes (5)

• The proportion of participants with favorable outcome

  9 months after treatment initiation

• The proportion of participants with favorable outcome

  24 months after treatment initiation

• The proportion of participants with sputum conversion

  2 months from treatment initiation

• Time to sputum conversion

  9 months after treatment initiation

• the incidence of grade 3 or worse AEs and SAEs

  24 months after treatment initiation

Study Arms (1)

Experimental arm

EXPERIMENTAL

All enrolled participants will receive the all-oral, shorter-course BLMZ regimen for a total of 9 months from end-TB study, as described in the Intervention section.

Drug: BLMZ

Interventions

BLMZ DRUG

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

Experimental arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Sputum or respiratory lavage fluid collected during the screening period is culture-positive for Mycobacterium tuberculosis, with DST results indicating Rifampicin resistance and susceptibility to at least one of MFX or LFX.
• Females of childbearing potential are not pregnant (as confirmed by a negative pregnancy test), voluntarily agree to pregnancy testing, and are willing to use highly effective contraception from the time of ICF signing until 3 months after the end of study treatment.
• For males of reproductive potential, use condoms or other methods to ensure effective contraception for their partner.
• Females who are breastfeeding are willing to discontinue breastfeeding from the time of ICF signing until 3 months after the end of study treatment.
• Voluntary acceptance of HIV testing; if the result is positive, voluntary acceptance of antiretroviral therapy.

You may not qualify if:

• 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.
• （Note: If the investigator judges that the benefit of participating in this study is higher and obtains the participant's consent, the prohibited medication should be discontinued with an adequate washout period before participation.）
• Known history of hypersensitivity to any drug in the protocol.
• Current participation in any other investigational drug clinical trial.
• Presence of cardiovascular disease risk at screening:
• QTcF interval \>450 milliseconds (ms). (Note: If QTcF \>450 ms is detected, one unscheduled visit during the screening period is allowed for re-assessment.)
• History of clinically significant arrhythmia within 60 days prior to enrollment, which in the investigator's opinion may increase risk upon study participation.
• Decompensated heart failure.
• Grade 3 hypertension not at control target.
• Abnormal thyroid function.
• Abnormal serum calcium, magnesium, or potassium levels. (Note: Isolated electrolyte disturbances without underlying disease may be considered for re-screening after corrective treatment.)
• Other conditions deemed by the investigator to pose a cardiovascular disease risk.
• History of optic neuropathy or peripheral neuropathy, which in the investigator's opinion may progress/worsen during the study or is unsuitable for study participation.

Sponsors & Collaborators

• Huashan Hospital: collaborator
• Beijing Chest Hospital: lead
• National Medical Center for Infectious Diseases: collaborator

Study Sites (3)

The Third People's Hospital in Aksou

Aksu, Xinjiang, China

Location

Hetian Prefecture Infectious Diseases Hospital

Hetian, Xinjiang, China

Location

Center of Disease Prevention and Control in Kashi Area

Kashgar, Xinjiang, China

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis; Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Naihui Chu, Medical Doctor, Professor

CONTACT

0086-010-89509301; dongchu1994@sina.com

Wenjuan Nie, Medical Doctor, Professor

CONTACT

0086-010-89509301; 94642975@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)