RECRUITING

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

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Conditions

Clostridium DifficileClostridium Difficile InfectionsClostridium Difficile Infection RecurrenceClostridioides Difficile InfectionClostridioides Difficile Infection RecurrenceCDIC. Diff InfectionRecurrent Clostridium Difficile InfectionC.Difficile DiarrheaDiarrhea Infectious

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-05-20
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06237452

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.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mary Garfield
CONTACT
857-706-1427
Consortium02-ctinquiries@vedantabio.com
Steven Shiff, MD
CONTACT
857-706-1427
Consortium02-ctinquiries@vedantabio.com

Study Locations (Sites)

Advanced Gastroenterology, P.C.
Chandler, Arizona, 85224
United States
Om Research, LLC
Apple Valley, California, 92307
United States
Science 37 Inc
Culver City, California, 90230
United States
North America Research Institute
San Dimas, California, 91773
United States
Clinical Trials Management Services
Thousand Oaks, California, 91360
United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
United States
Medical Research Center of Connecticut
Hamden, Connecticut, 06518
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
Gastro Florida
Clearwater, Florida, 33756
United States
Proactive Clinical Research, LLC
Fort Lauderdale, Florida, 33308
United States
Encore Borland-Groover Clinical Research
Jacksonville, Florida, 32256
United States
GI Pros Research
Naples, Florida, 34102
United States
Advanced Medical Research Center
Port Orange, Florida, 32127
United States
KM International Research Operation LLC
Saint Cloud, Florida, 34769
United States
James A. Haley Veterans' Hospital
Tampa, Florida, 33612
United States
International Center for Research
Tampa, Florida, 33614
United States
Summit Clinical Research, LLC
Athens, Georgia, 30607
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Metro Infectious Disease Consultants
Decatur, Georgia, 30033
United States
Regional Infectious Diseases and Infusion Center, Inc.
LaGrange, Georgia, 30240
United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060
United States
Snake River Research, PLLC
Idaho Falls, Idaho, 83404
United States
Metro Infectious Disease Consultants
Burr Ridge, Illinois, 60527
United States
NorthShore University Health System - Evanston Hospital
Evanston, Illinois, 60201
United States
Innovative Clinical Research Center, LLC (ICRC)
Island Lake, Illinois, 60042
United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
United States
Deaconess GI Specialty Center
Newburgh, Indiana, 47630
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
IDC Clinical Research, LLC
Wichita, Kansas, 67211
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
LTC Charles S. Kettles VA Medical Center
Ann Arbor, Michigan, 48105
United States
Henry Ford Health
Detroit, Michigan, 48202
United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
United States
MNGI Digestive Health, PA
Plymouth, Minnesota, 55446
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Delta Gastroenterology and Endoscopy Center
Southaven, Mississippi, 38671
United States
University of Missouri
Columbia, Missouri, 65212
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
St. Charles Clinical Research
Weldon Spring, Missouri, 63304
United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
United States
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Northwell Health Division of Infectious Diseases
Manhasset, New York, 11030
United States
NYU Grossman School of Medicine
New York, New York, 10016
United States
Manhattan Clinical Research, LLC
New York, New York, 10279
United States
Syracuse VA Medical Center
Syracuse, New York, 13210
United States
Toledo Institute of Clinical Research
Toledo, Ohio, 43617
United States
Oklahoma City Veterans Affairs Healthcare System
Oklahoma City, Oklahoma, 73104
United States
Susquehanna Research Group - Gastroenterology
Harrisburg, Pennsylvania, 17110
United States
Guthrie Medical Group, PC
Sayre, Pennsylvania, 18840
United States
Frontier Clinical Research
Uniontown, Pennsylvania, 15401
United States
Lowcountry Infectious Diseases, P.A.
Charleston, South Carolina, 29414
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
North Texas Infectious Disease Consultants, P.A.
Dallas, Texas, 75246
United States
University of Houston College of Pharmacy
Houston, Texas, 77204
United States
BioStar Clinical Research
Katy, Texas, 77494
United States
Simcare Medical Research, LLC
Sugar Land, Texas, 77478
United States
Seattle Infectious Disease Clinic
Seattle, Washington, 98101
United States

Collaborators and Investigators

Sponsor: Vedanta Biosciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-20
Study Completion Date2027-10

Study Record Updates

Study Start Date2024-05-20
Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

  • 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