Clinical Trial

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

Study acronym: INSPIRE-TB
Recruiting Phase 3
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Summary
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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-10-05; most recent amendment 2025-04-01.
Status change: Not Yet Recruiting → Recruiting 2023-03-20
Trial Details
NCT Number NCT05081401
Lead Sponsor Huashan Hospital
Conditions Multidrug Resistant Tuberculosis, Rifampicin Resistant Tuberculosis, Pre-XDR-TB
Enrollment 1,050 participants
Start Date 2022-05-23
Primary Completion 2026-12-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-06