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Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)

Study acronym: INSPIRE-TB
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Phase: Not specified to Phase 3v3 Show 9 more changesShow less
    • Enrollment target: 3000 to 1050
    • Primary completion date: Dec 1, 2025 to Dec 1, 2026
    • Primary endpoint revised
    • Study completion date: Dec 1, 2025 to Dec 1, 2027
    • Interventions: This is a non-intervention observational study. (Other) to A1 (Combination Product), A2a (Combination Product), A2b (Combination Product), A2c (Combination Product), A3 (Combination Product), A4…
    • Eligibility criteria expanded, about 62 words
    • Secondary endpoints: 4 to 6
    • Study description expanded, about 19 words
    • Study arms: 1 to 10
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Dec 1, 2023 to Dec 1, 2025
    • Start date changed from estimate of Dec 30, 2021 to May 23, 2022
    • Site details revised at 5 of 5 sites
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 INSPIRE-TB study is a pragmatic, multicentre, randomised, controlled, non-inferiority open-label trial to evaluate the efficacy and safety of seven 9-month oral regimens compared to a 9-month standard of care (SOC) regimen in RR-TB participants susceptible to fluoroquinolones, and a bedaquiline-containing 9-month oral regimen compared to a 20-month conventional regimen in RR-TB participants resistant to fluoroquinolones
Trial Details
NCT Number NCT05081401
Lead Sponsor Huashan Hospital
Conditions
(from sponsor)		 Multidrug Resistant Tuberculosis, Rifampicin Resistant Tuberculosis, Pre-XDR-TB
Related terms Tuberculosis, Multidrug-Resistant
Enrollment 1,050 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov