Overview

Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant TuberculosisBDLL Chinese Cohort

Status:
ACTIVE_NOT_RECRUITING

Trial end date:
2027-06-30

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

Huashan Hospital

Collaborator:

Beijing Chest Hospital

Treatments:

bedaquiline
Clofazimine
Fumigant 93
Levofloxacin
Linezolid
OPC-67683