Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis:BDLL Chinese Cohort
Summary
This is an investigational, prospective, multicenter, single-arm, open label trial. The goal of this clinical trial is to evaluate the efficacy and safety of a 6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) or Clofazimine (CFZ, C), or BDLLfxC regimen, to treat rifampin-resistant pulmonary tuberculosis (RR-TB) in Chinese teenagers and adults (aged 12 years or above). The main questions it aims to answer are: * Is BDLLfxC regimen effective to treat RR-TB in Chinese participants? * Is BDLLfxC regimen safe in Chinese RR-TB participants? Participants will take BDLLfxC regimen to treat their RR-TB. There will be no additional hospital visits, laboratory tests or radiological examinations other than routine clinical practice.
Timeline
- Start
- 2024-11-27
- Primary completion
- 2027-02-28
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | — |
| Subject | Clofazimine | Small molecule | 100 mg | — |
| Subject | Delamanid | Small molecule | 50 mg | — |
| Subject | Delamanid | Small molecule | 200 mg | — |
| Subject | Levofloxacin | Small molecule | 500 mg | — |
| Subject | Levofloxacin | Small molecule | 750 mg | — |
| Subject | Levofloxacin | Small molecule | 1000 mg | — |
| Subject | Linezolid | Other / unclassified | 450 mg | — |
| Subject | Linezolid | Other / unclassified | 600 mg | — |