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NOT YET RECRUITING
NCT07198685
NA

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

Sponsor: Wuhan Pulmonary Hospital

View on ClinicalTrials.gov

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.

Official title: 6 Months of Bedaquiline, Delamanid, Linezolid and Levoffoxacin in RR-TB Patients in Hubei Province

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2025-09-30

Completion Date

2028-09-30

Last Updated

2025-09-30

Healthy Volunteers

No

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