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A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Ve303 for Prevention of Recurrent Clostridioides Difficile Infection: The Restorative303 Study

Date:

05/20/2025

Lead Investigators:

Summary

The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).