drugset / Trial / NCT06649721

Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis:BDLL Chinese Cohort

NCT06649721

Phase 3 Active not recruiting 120 enrolled Huashan Hospital Beijing Chest Hospital · collab
NaSingle-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
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