Status: Recruiting
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
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
Participants needed: 1,050
Trial details
Phase: Phase 3Age: 16-75Biological sex: AllType: InterventionalSponsor: Huashan HospitalUpdated: Apr 6, 2025Locations: 5
Eligibility criteria
Male or female patients aged 16-75 years with weight over 30kg, regardless of HI... [+2]
Known allergies, hypersensitivity, or contraindication to any of the study drugs... [+4]