Inclusion criteria | |
• Documented pulmonary TB due to strains of Mycobacterium tuberculosis resistant to rifampin and susceptible to fluoroquinolones • Diagnosed by validated rapid molecular test • ≥ 15 years of age • Willingness to use effective contraception • Provision of informed consent for study participation • Residence in a dwelling that can be located by study staff and an expectation to remain in the area for the duration of the study | |
Exclusion criteria | |
• Patients with known allergies or hypersensitivity to any of the investigational drugs • Patients known to be pregnant or unwilling or unable to stop breastfeeding an infant • Patients unable to comply with treatment or follow-up schedule • Patients with exposure (intake for 30 days or more) in the past 5 years to bedaquiline, delamanid, linezolid, or clofazimine, or with proven or likely resistance to bedaquiline, delamanid, linezolid, or clofazimine • Patients who have received second-line drugs for 15 days or more prior to the screening visit date in the current MDR-TB treatment episode • Patients with one or more of the following laboratory results: - Grade 3 or higher haemoglobin, calcium, magnesium, creatinine, or bilirubin - Grade 2 or higher potassium, aspartate aminotransferase, alanine aminotransferase, or total bilirubin - Albumin < 2.8 g/dL - Grade 4 result on any other screening laboratory tests • Patients with cardiac risk factors including ECG abnormalities (i.e. QTcF≥450 ms), pacemaker implant, and personal/family history of cardiovascular disease (i.e. long QT syndrome, left or right bundle branch block) • Patients requiring continued use of a contraindicated medication • Patients currently taking part in another trial of medicinal product • Patients with any condition (social or medical) which, in the opinion of the investigator, would make study participation unsafe |