6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province

NCT07198685 | Not Yet Recruiting DMC

• 1 other identifier: Wuhan PulmonaryH
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare the efficacy and safety of a 6-month all-oral regimen including Bedaquiline (BDQ,B), Delamanid (DLM,D), Linezolid (LZD, L), and Levofloxacin (LFX,L) to the the standard long - course treatment regimen within the Chinese population. The main questions it aims to answer are: Is the efficacy of short regimen non-inferior to standard regimen? Is the short regimen safe enough to replace the standard regimen? Participants will: Be given with either short or standard regimen for RR-TB treatment Be asked to complete the scheduled visit as planned.

Conditions

Treat to Target; Treatment Duration

Keywords

BDLL; RR/MDR-TB

Outcome Measures

Primary Outcomes (1)

• End of treatment outcome

  Number of individuals experiencing each tuberculosis treatment outcome (cure, completion, death, failure, lost-to-follow-up), assessed at the end of treatment by a clinician, based on culture results

  72 weeks after the treatment initiation

Secondary Outcomes (2)

• The median time to Sputum Culture Conversion

  Time Frame: 4-24 weeks after treatment initiation

• Final tuberculosis treatment outcome

  24, 48 and 72 weeks after treatment completion

Other Outcomes (1)

• The frequency of grade 3 or greater adverse events among patients

  72 weeks after treatment initiation

Study Arms (2)

test group

EXPERIMENTAL

6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) , as known as BDLL regimen Interventions: Drug: bedaquiline Drug: delamanid Drug: linezolid Drug: Levofloxacin

Drug: bedaquiline; Drug: Delamanid (DLM); Drug: Linezolid (LZD); Drug: Levofloxacin

Control group (Group A)

ACTIVE COMPARATOR

Six months of bedaquiline, linezolid, levofloxacin, cycloserine, and clofazimine, followed by 12 months of levofloxacin, cycloserine, and clofazimine.

Drug: bedaquiline; Drug: Delamanid (DLM); Drug: Linezolid (LZD); Drug: Levofloxacin; Drug: Cycloserine; Drug: Clofazimine

Interventions

bedaquiline DRUG

Administer 400 mg orally once daily for 2 weeks, followed by 200 mg orally three times a week for 22 weeks

Control group (Group A); test group

Delamanid (DLM) DRUG

Administer 100 mg orally, twice daily for 24 weeks.

Control group (Group A); test group

Linezolid (LZD) DRUG

Administer 600 mg orally, once daily for 24 weeks.

Control group (Group A); test group

Levofloxacin DRUG

test group:Administer 800 mg orally, once daily for 24 weeks;control group:Administer 800 mg orally, once daily for 72 weeks

Control group (Group A); test group

Cycloserine DRUG

Administer 250mg orally, twice daily for 72 weeks.

Control group (Group A)

Clofazimine DRUG

Administer 100 mg orally, once daily for 72 weeks

Control group (Group A)

Eligibility Criteria

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

You may qualify if:

• Patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an all-oral treatment regimen (short or long) under routine or operational conditions will be included.
• Aged between 18 and 65 years old.
• Have never used bedaquiline, delamanid, linezolid, or levofloxacin in the past, or have used them for no more than 4 weeks.
• Positive results of mycobacterial culture (either smear-positive or smear-negative) within the recent one month, and no effective anti-tuberculosis treatment received within this one-month period; or in the absence of recent sputum culture results, smear-positive sputum and no effective anti-tuberculosis treatment administered.
• No history of respiratory failure or cardiac insufficiency, and no clinically significant arrhythmia manifestations on electrocardiogram.
• During the treatment and follow - up periods, patients are required to take medications as per the research project requirements, complete treatment monitoring, and promptly report any adverse reactions to the attending physicians.
• Voluntarily participate in this study and sign the informed consent form.

You may not qualify if:

• Individuals with a history of optic neuropathy or peripheral neuropathy, whom the researchers believe may experience progression/worsening during the study or are not suitable for participation in this research.
• Chronic active hepatitis, with positive results for three items: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and hepatitis B core antibody (anti - HBc), or HBV - DNA \> 1000 CPs/mL, accompanied by elevated ALT/AST. Elevation of ALT or AST is ≥3 times the upper limit of the normal value, or elevation of total bilirubin and direct bilirubin is ≥2 times the upper limit of the normal value (if it is a temporary elevation, patients can be enrolled after recovery from treatment).
• Severe renal insufficiency (creatinine clearance rate (CrCl) less than 30 mL/min).
• Individuals who have participated in clinical trials of other unlisted new drugs within the past three months.
• Known congenital QT interval prolongation, presence of any disease that can prolong the QT interval, or a QTc \> 450 ms.
• Pregnant women or women who may be pregnant.
• Any cardiac diseases capable of inducing arrhythmia, such as severe hypertension (poorly controlled blood pressure), left ventricular hypertrophy (including hypertrophic cardiomyopathy), or congestive heart failure accompanied by a reduced left ventricular ejection fraction.
• A history of known, untreated, and persistent hypothyroidism. Combined with hematogenous disseminated tuberculosis and central nervous system tuberculosis.
• A history of allergy or a known allergy to any investigational medicinal product or related substances.
• HIV-positive.

Sponsors & Collaborators

• Wuhan Pulmonary Hospital: lead

MeSH Terms

Interventions

bedaquiline; OPC-67683; Linezolid; Levofloxacin; Cycloserine; Clofazimine

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Isoxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Phenazines; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Shuang Wei, Doctor, director of hospital

CONTACT

+8602783602347; shuangwei@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shuang Wei,Vice-President

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: September 30, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share