Evaluating Newly Approved Drugs for Multidrug-resistant TB
Georgia, India, Kazakhstan754 participantsStarted 2016-12
Plain-language summary
endTB Clinical Trial a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB).
Who can participate
Age range15 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Has documented pulmonary tuberculosis due to strains of M. tuberculosis resistant to rifampin (RIF) and susceptible to fluoroquinolones, diagnosed by validated rapid molecular test;
✓. Is ≥ 15 years of age;
✓. Is willing to use contraception: pre-menopausal women or women whose last menstrual period was within the preceding year, who have not been sterilized must agree to use contraception unless their partner has had a vasectomy; men who have not had a vasectomy must agree to use condoms;
✓. Provides informed consent for study participation; additionally a legal representative of patients considered minor per local laws should also provide consent;
✓. Lives in a dwelling that can be located by study staff and expects to remain in the area for the duration of the study.
Exclusion criteria
✕. Has known allergies or hypersensitivity to any of the investigational drugs;
✕. Is known to be pregnant or is unwilling or unable to stop breast-feeding an infant;
✕. Is unable to comply with treatment or follow-up schedule;
✕. Any condition (social or medical) which, in the opinion of the site principal investigator, would make study participant unsafe;
✕. a. Has had exposure (intake of the drug for 30 days or more) in the past five years to bedaquiline, delamanid, linezolid, or clofazimine, or has proven or likely resistance to bedaquiline, delamanid, linezolid, or clofazimine (e.g., household contact of a DR-TB index case who died or experienced treatment failure after treatment containing bedaquiline, delamanid, linezolid, or clofazimine or had resistance to one of the listed drugs); exposure to other anti-TB drugs is not a reason for exclusion.