CompletedPhase 3

Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)

India, Kazakhstan, Lesotho323 participantsStarted 2020-04-06

Plain-language summary

endTB-Q Clinical Trial is a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of two new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB) with fluoroquinolone resistance.

Who can participate

Age range15 Years

SexALL

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Inclusion criteria

✓. Has documented pulmonary tuberculosis due to strains of M. tuberculosis resistant to rifampin (RIF) and not susceptible to fluoroquinolones, according to a validated rapid molecular test. Patients with RIF-resistant TB who are unable to tolerate fluoroquinolones (history of severe adverse events, allergies, hypersensitivity) are also eligible, regardless of resistance/susceptibility to fluoroquinolones;
✓. 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

✕. patients whose treatment has failed according to the WHO definition and who are being considered for a new treatment regimen;
✕. patients starting a new treatment regimen after having been "lost to follow-up" according to the WHO definition and,
✕. patients in whom treatment failure is suspected (but not confirmed according to WHO definition), who are being considered for a new treatment regimen, and for whom the Clinical Advisory Committee (CAC) consultation establishes eligibility.

What they're measuring

Week 73 Efficacy: Proportion of participants with favorable outcome at Week 73

Timeframe: Week 73 after randomization

Trial details

NCT IDNCT03896685

SponsorMédecins Sans Frontières, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-04

View on ClinicalTrials.gov More Tuberculosis, Multidrug-Resistant trials