Shorter, All-Oral, Personalized Treatment Regimens for Rifampicin-Resistant Tuberculosis Including Pre-XDR TB Patients

What this Trial Is About

The trial investigates treatment options for patients with rifampicin-resistant tuberculosis RR-TB, including those resistant or susceptible to fluoroquinolones. It compares seven different 9-month oral drug combinations to the current 9-month standard of care for fluoroquinolone-susceptible RR-TB, and a 9-month bedaquiline-containing regimen to a 20-month conventional regimen for fluoroquinolone-resistant RR-TB. This Phase 3, randomized, controlled, open-label study aims to evaluate if these new shorter treatments are as effective and safe as existing therapies. Participants susceptible to fluoroquinolones receive one of several oral regimens combining drugs like bedaquiline, linezolid, fluoroquinolones moxifloxacin or levofloxacin, cycloserine, clofazimine, and pyrazinamide. Treatment lasts 9 months, with possible extension by 2 months for certain conditions. For fluoroquinolone-resistant participants, the experimental regimen includes bedaquiline, cycloserine, clofazimine, linezolid, and pyrazinamide for 9 months, compared to a 20-month standard regimen. Drug resistance is tested at baseline to adjust medications accordingly. During the study, participants undergo assessments including sputum culture tests and safety evaluations up to 21 months after randomization. Researchers monitor treatment outcomes such as cure rates, time to culture conversion, adverse effects severity, mortality, and specific drug-related side effects. Participants are followed closely with clinical and laboratory tests to evaluate the effectiveness and safety of these regimens throughout the treatment and follow-up period.

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