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

Study acronym: INSPIRE-BDLL
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 34 of 34 sites
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 39 to 34
    • Primary completion date: Jun 30, 2027 to Feb 28, 2027
    • Start date changed from estimate of Nov 15, 2024 to Nov 27, 2024
    v3
  3. Study sites: 31 to 39
    • Start date: Nov 1, 2024 to Nov 15, 2024
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06649721
Lead Sponsor Huashan Hospital
Collaborators: Beijing Chest Hospital
Conditions
(from sponsor)		 Drug-resistant Tuberculosis, Pulmonary Tuberculosis, Rifampin-resistant Tuberculosis
Related terms Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov