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 —