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A Double-Blind Placebo-Controlled Phase 2 Study of VE303 for Prevention of Recurrent Clostridium (Clostridioides) Difficile Infection (VE303-002)

Study Details

CONSORTIUM is a randomized, double-blind phase 2 study to evaluate safety, tolerability, PK/PD, and efficacy of VE303 in prevention of subsequent CDI-associated diarrhea compared with placebo following completion of at least 1 successful course of standard-of-care (SOC) antibiotics. 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 rCDI.

VE303-002

Learn More

ClinicalTrials.gov NCT number
NCT03788434
Principal Investigator(s)
Michael Parry, MD
Sponsor(s)
Vedanta Biosciences, Inc
Contact
Maryanne Ducey, DC, RN at 203-358-8879
or officeofresearch@stamhealth.org

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