Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB

• Status: Not yet recruiting
• Trial end date: 2025-07-01

Summary

Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis (TB) that is resistant to at least isoniazid and rifampicin, the two most important anti-TB drugs. It occurs in 3.6% of newly diagnosed TB patients in the world and 17% of patients who have been previously treated. In 2017, approximately 600,000 people were estimated to have acquired MDR-TB. However, only 25% of persons with MDR-TB were diagnosed and started on treatment, reflecting inadequate diagnostic capacity and lack of TB treatment capacity.

In this multicenter, randomized, partially blinded, four-arm, phase 2 study, the investigators will examine the efficacy and safety of an all-oral regimen of bedaquiline, delamanid, levofloxacin, linezolid, and clofazimine given for 16, 24, 32 or 40 weeks

• Phase: Phase 2

Details

• Lead Sponsor: Boston University
• Collaborators: De La Salle Health Sciences Institute, Philippines; Harvard Medical School; Harvard Medical School (HMS and HSDM); National Institute of Allergy and Infectious Diseases (NIAID); National Lung Hospital, Vietnam; Novartis Pharmaceuticals; Otsuka Pharmaceutical Co., Ltd.; Pfizer; United States Department of Defense; University of California, San Francisco; University of Colorado, Denver; Westat
• Treatments: Bedaquiline; Clofazimine; Diarylquinolines; Levofloxacin; Linezolid; Ofloxacin