drugset / Trial / NCT07198685
6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-09-30
- Primary completion
- 2027-09-30
- Completion
- 2028-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clofazimine | Small molecule | 100 mg | Oral |
| Comparator | Cycloserine | Small molecule | 250 mg | Oral |
| Subject | Delamanid | Small molecule | 100 mg | Oral |
| Subject | Levofloxacin | Small molecule | 800 mg | Oral |
| Background | Bedaquiline | Small molecule | 200 mg | Oral |
| Background | Linezolid | Other / unclassified | 600 mg | Oral |
Indications
No indication recorded.