VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Description

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).

Conditions

Clostridium Difficile, Clostridium Difficile Infections, Clostridium Difficile Infection Recurrence, Clostridioides Difficile Infection, Clostridioides Difficile Infection Recurrence, CDI, C. Diff Infection, Recurrent Clostridium Difficile Infection, C.Difficile Diarrhea, Diarrhea Infectious

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Study Overview

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Study Details

Study overview

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).

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Condition
Clostridium Difficile
Intervention / Treatment

-

Contacts and Locations

Chandler

Advanced Gastroenterology, P.C., Chandler, Arizona, United States, 85224

Apple Valley

Om Research, LLC, Apple Valley, California, United States, 92307

Culver City

Science 37 Inc, Culver City, California, United States, 90230

San Dimas

North America Research Institute, San Dimas, California, United States, 91773

Thousand Oaks

Clinical Trials Management Services, Thousand Oaks, California, United States, 91360

Torrance

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States, 90502

Hamden

Medical Research Center of Connecticut, Hamden, Connecticut, United States, 06518

Hartford

Hartford Hospital, Hartford, Connecticut, United States, 06102

Clearwater

Gastro Florida, Clearwater, Florida, United States, 33756

Fort Lauderdale

Proactive Clinical Research, LLC, Fort Lauderdale, Florida, United States, 33308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    12 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Vedanta Biosciences, Inc.,

    Study Record Dates

    2027-10