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Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort

Study acronym: INSPIRE-CODA
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 1, 2025 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 39 of 39 sites
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2023 to Dec 22, 2023
    • Site details revised at 39 of 39 sites
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Primary endpoint revisedv2 Show 9 more changesShow less
    • Enrollment target: 198 to 186
    • Study sites: 38 to 39
    • Primary completion date: May 31, 2026 to Oct 1, 2026
    • Study completion date: Aug 31, 2026 to Dec 31, 2026
    • Start date: Oct 21, 2023 to Nov 1, 2023
    • Eligibility criteria expanded, about 365 words
    • Secondary endpoints revised (3)
    • Collaborators expanded, about 6 words
    • Study title expanded, about 1 word
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main questions it aims to answer are: * Is the efficacy of short regimen non-inferior to standard regimen? * Is the short regimen safe enough to replace the standard regimen? Participants will: * Be given with either short or standard regimen for RR-TB treatment * Be asked to complete the scheduled visit as planned.
Trial Details
NCT Number NCT06081361
Lead Sponsor Beijing Chest Hospital
Collaborators: National Medical Center for Infectious Diseases
Conditions
(from sponsor)		 Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis
Related terms Tuberculosis, Tuberculosis, Pulmonary
Enrollment 186 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov