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Table 3 Inclusion and exclusion criteria for study.

From: Evaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial

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