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6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province
Sponsor: Wuhan Pulmonary Hospital
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
Conditions
Interventions
bedaquiline
Administer 400 mg orally once daily for 2 weeks, followed by 200 mg orally three times a week for 22 weeks
Delamanid (DLM)
Administer 100 mg orally, twice daily for 24 weeks.
Linezolid (LZD)
Administer 600 mg orally, once daily for 24 weeks.
Levofloxacin
test group:Administer 800 mg orally, once daily for 24 weeks;control group:Administer 800 mg orally, once daily for 72 weeks
Cycloserine
Administer 250mg orally, twice daily for 72 weeks.
Clofazimine
Administer 100 mg orally, once daily for 72 weeks