Randomized Phase 2 Study of VE303 for Prevention of Recurrent Clostridium Difficile Infection (CONSORTIUM)

Brief description of study

CONSORTIUM is a randomized, double-blind phase 2 study to evaluate safety, tolerability, PK/PD, and efficacy of VE303 in adult subjects with 1 or more recurrences of Clostridium difficile infection (CDI), including the current episode. VE303 or placebo capsules will be taken orally for 14 days after completion of a course of standard of care antibiotics. The proportion of subjects experiencing a confirmed CDI recurrence, within 8 weeks after the first dose of study treatment, will be compared across the study arms to understand the effectiveness of VE303 in preventing subsequent rCDI. Approximately 146 subjects with: a history of CDI, diarrhea, a positive C. difficile toxin stool sample test, and who have responded to standard-of-care (SOC) antibiotic treatment, will be enrolled in the study. Participants will be randomly assigned, in a 1:1:1 ratio to 1 of 3 treatment arms (VE303 high dose, VE303 low dose, and placebo). Participants and their doctors will not know which treatment arm is assigned.

Clinical Study Identifier: s19-00505
Principal Investigator: Jordan E Axelrad.

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