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

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

NCT Number	NCT03828201
Lead Sponsor	Boston University Collaborators: Novartis Pharmaceuticals, Pfizer, Otsuka Pharmaceutical Co., Ltd., University of California, San Francisco, National Institute of Allergy and Infectious Diseases (NIAID), University of Colorado, Denver, Harvard Medical School (HMS and HSDM), National Lung Hospital, Vietnam, TB-HIV Innovations & Clinical Research Foundation Corp, Philippines
Conditions	Tuberculosis, Multidrug-Resistant
Enrollment	271 participants
Start Date	2022-06-07
Primary Completion	2027-05 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-07-08