drugset / Trial / NCT05081401
Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2022-05-23
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | — | Oral |
| Subject | Clofazimine | Small molecule | — | Oral |
| Subject | Cycloserine | Small molecule | — | Oral |
| Subject | E | Unknown | — | Oral |
| Subject | H | Unknown | — | Oral |
| Subject | Levofloxacin | Small molecule | — | Oral |
| Subject | Linezolid | Other / unclassified | 300 mg | Oral |
| Subject | Linezolid | Other / unclassified | 600 mg | Oral |
| Subject | Moxifloxacin | Small molecule | — | Oral |
| Subject | Pto | Unknown | — | Oral |
| Subject | Pyrazinamide | Small molecule | — | Oral |