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

NCT07198685 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-09-30

No results posted yet for this study

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

Interventions

DRUG

bedaquiline

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

DRUG

Delamanid (DLM)

Administer 100 mg orally, twice daily for 24 weeks.

DRUG

Linezolid (LZD)

Administer 600 mg orally, once daily for 24 weeks.

DRUG

Levofloxacin

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

DRUG

Cycloserine

Administer 250mg orally, twice daily for 72 weeks.

DRUG

Clofazimine

Administer 100 mg orally, once daily for 72 weeks

Sponsors & Collaborators

  • Wuhan Pulmonary Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-09-30
Completion
2028-09-30

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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 NCT07198685 on ClinicalTrials.gov