VE303 for Prevention of Recurrent Clostridioides Difficile Infection
- Conditions
- Clostridioides Difficile Infection RecurrenceDiarrhea InfectiousClostridium DifficileClostridium Difficile Infection RecurrenceC.Difficile DiarrheaClostridioides Difficile InfectionClostridium Difficile InfectionsC. Diff InfectionRecurrent Clostridium Difficile InfectionCDI
- Interventions
- Biological: PlaceboBiological: VE303
- Registration Number
- NCT06237452
- Lead Sponsor
- Vedanta Biosciences, Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 852
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subjects assigned to the placebo arm will take 3 placebo capsules per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode. VE303 VE303 Subjects assigned to the VE303 arm will take 3 capsules containing VE303 per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.
- Primary Outcome Measures
Name Time Method CDI Recurrence Rate at Week 8 8 weeks Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (136)
UMHAT Burgas AD
🇧🇬Burgas, Bulgaria
MBAL Dr. Ivan Seliminski - Sliven AD
🇧🇬Sliven, Bulgaria
AOU Pisana - Stabilimento di Cisanello
🇮🇹Pisa, Italy
Hospital Universitario La Paz - UCICEC
🇪🇸Madrid, Spain
Advanced Gastroenterology, P.C.
🇺🇸Chandler, Arizona, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Om Research, LLC
🇺🇸Apple Valley, California, United States
Science 37 Inc
🇺🇸Culver City, California, United States
VA San Diego Healthcare System
🇺🇸San Diego, California, United States
North America Research Institute
🇺🇸San Dimas, California, United States
Clinical Trials Management Services
🇺🇸Thousand Oaks, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Medical Research Center of Connecticut
🇺🇸Hamden, Connecticut, United States
Gastro Florida
🇺🇸Clearwater, Florida, United States
Proactive Clinical Research, LLC
🇺🇸Fort Lauderdale, Florida, United States
Encore Borland-Groover Clinical Research
🇺🇸Jacksonville, Florida, United States
GI Pros Research
🇺🇸Naples, Florida, United States
Advanced Medical Research Center
🇺🇸Port Orange, Florida, United States
KM International Research Operation LLC
🇺🇸Saint Cloud, Florida, United States
James A. Haley Veterans' Hospital
🇺🇸Tampa, Florida, United States
International Center for Research
🇺🇸Tampa, Florida, United States
Summit Clinical Research, LLC
🇺🇸Athens, Georgia, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Metro Infectious Disease Consultants
🇺🇸Burr Ridge, Illinois, United States
Regional Infectious Diseases and Infusion Center, Inc.
🇺🇸LaGrange, Georgia, United States
Gastrointestinal Specialists of Georgia
🇺🇸Marietta, Georgia, United States
Snake River Research, PLLC
🇺🇸Idaho Falls, Idaho, United States
NorthShore University Health System - Evanston Hospital
🇺🇸Evanston, Illinois, United States
Innovative Clinical Research Center, LLC (ICRC)
🇺🇸Island Lake, Illinois, United States
Indiana University Health University Hospital
🇺🇸Indianapolis, Indiana, United States
Deaconess GI Specialty Center
🇺🇸Newburgh, Indiana, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
IDC Clinical Research, LLC
🇺🇸Wichita, Kansas, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
LTC Charles S. Kettles VA Medical Center
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health
🇺🇸Detroit, Michigan, United States
Corewell Health William Beaumont University Hospital
🇺🇸Royal Oak, Michigan, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
MNGI Digestive Health, PA
🇺🇸Plymouth, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Delta Gastroenterology and Endoscopy Center
🇺🇸Southaven, Mississippi, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
St. Charles Clinical Research
🇺🇸Weldon Spring, Missouri, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Northwell Health Division of Infectious Diseases
🇺🇸Manhasset, New York, United States
NYU Grossman School of Medicine
🇺🇸New York, New York, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Manhattan Clinical Research, LLC
🇺🇸New York, New York, United States
Syracuse VA Medical Center
🇺🇸Syracuse, New York, United States
Toledo Institute of Clinical Research
🇺🇸Toledo, Ohio, United States
Oklahoma City Veterans Affairs Healthcare System
🇺🇸Oklahoma City, Oklahoma, United States
Susquehanna Research Group - Gastroenterology
🇺🇸Harrisburg, Pennsylvania, United States
Guthrie Medical Group, PC
🇺🇸Sayre, Pennsylvania, United States
Frontier Clinical Research
🇺🇸Uniontown, Pennsylvania, United States
Ralph H. Johnson VA Health Care System
🇺🇸Charleston, South Carolina, United States
Lowcountry Infectious Diseases, P.A.
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
North Texas Infectious Disease Consultants, P.A.
🇺🇸Dallas, Texas, United States
University of Houston College of Pharmacy
🇺🇸Houston, Texas, United States
BioStar Clinical Research
🇺🇸Katy, Texas, United States
Simcare Medical Research, LLC
🇺🇸Sugar Land, Texas, United States
Seattle Infectious Disease Clinic
🇺🇸Seattle, Washington, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Melbourne Health
🇦🇺Parkville, Victoria, Australia
Erasme University Hospital - Infectiology Department
🇧🇪Anderlecht, Belgium
Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Medical Center Excelsior OOD, Base 1
🇧🇬Sofia, Sofia-Grad, Bulgaria
Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
🇧🇬Gorna Oryahovitsa, Bulgaria
Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOOD
🇧🇬Lom, Bulgaria
Medicinski centar Hipokrat-N EOOD
🇧🇬Plovdiv, Bulgaria
Alberta Health Services (AHS) - Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
CaRe Clinic
🇨🇦Red Deer, Alberta, Canada
The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Research St. Josephs Hamilton
🇨🇦Hamilton, Ontario, Canada
Viable Clinical Research Corporation
🇨🇦Scarborough, Ontario, Canada
INTERMED groupe santé
🇨🇦Chicoutimi, Quebec, Canada
Centre Hospitalier de l Universite Laval (CHUL)
🇨🇦Quebec, Canada
Nemocnice Kyjov, p.o.
🇨🇿Kyjov, Czech Republic
Fakultni Nemocnice Ostrava
🇨🇿Ostrava-Poruba, Czech Republic
Aarhus University Hospital
🇩🇰Aarhus, Central Jutland, Denmark
ISR-GEO Med Res Clin Healthycore
🇬🇪Tbilisi, Georgia
LTD "Emergency Cardiology Center named by Acad.G.Chapidze"
🇬🇪Tbilisi, Georgia
LTD "Academician Vakhtang Bochorishvili Clinic"
🇬🇪Tbilisi, Georgia
LTD "Aversi Clinic"
🇬🇪Tbilisi, Georgia
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. sz. Belgyogyaszati Klinika
ðŸ‡ðŸ‡ºSzeged, Csongrád, Hungary
Semmelweis Egyetem
ðŸ‡ðŸ‡ºBudapest, Hungary
Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház NyÃregyházi Jósa András Tagkórház
ðŸ‡ðŸ‡ºNyÃregyháza, Hungary
Our Lady of Lourdes Hospital
🇮🇪Drogheda, Louth, Ireland
Rabin Medical Center - Beilinson Hospital
🇮🇱Petah Tikva, HaMerkaz, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, HaMerkaz, Israel
Shamir Medical Center (Assaf Harofeh)
🇮🇱Zerifin, HaMerkaz, Israel
Hadassah Medical Centre
🇮🇱Jerusalem, Yerushalayim, Israel
Rambam Health Care Campus
🇮🇱Haifa, Israel
The Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
PO A. Manzoni di Lecco, ASST Lecco
🇮🇹Lecco, Lombardia, Italy
Ospedale Isola Tiberina Gemelli Isola
🇮🇹Roma, Italy
Leids Universitair Medisch Centrum (LUMC)
🇳🇱Leiden, Zuid-Holland, Netherlands
Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
🇳🇱Utrecht, Netherlands
NZOZ VIVAMED Jadwiga Miecz
🇵🇱Warszawa, Mazowieckie, Poland
Gyncentrum sp. z o.o.
🇵🇱Katowice, Slaskie, Poland
Unidade Local De Saude Do Alto Ave E.P.E.
🇵🇹Guimaraes, Braga, Portugal
Unidade Local De Saude De Almada-Seixal E.P.E.
🇵🇹Almada, Lisboa, Portugal
CCAB Centro Clinico Academico Braga Associacao - ULS Braga
🇵🇹Braga, Portugal
Unidade Local De Saude De Coimbra E.P.E.
🇵🇹Coimbra, Portugal
Unidade Local de Saúde da Guarda (ULSG)
🇵🇹Guarda, Portugal
Unidade Local De Saude De Santo Antonio E.P.E.
🇵🇹Porto, Portugal
Unidade Local De Saude De Gaia/Espinho E.P.E.
🇵🇹Vila Nova de Gaia, Portugal
Hospital Universitario Mutua de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital Universitario Puerta De Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Complexo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital General Universitario Dr Balmis
🇪🇸Alicante, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital de La Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Virgen De La Macarena
🇪🇸Sevilla, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Royal Devon University Healthcare NHS Trust
🇬🇧Exeter, Devon, United Kingdom
The Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
NHS Lothian - Western General Hospital
🇬🇧Edinburgh, United Kingdom
St.Thomas' Hospital
🇬🇧London, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
Morriston Hospital
🇬🇧Swansea, United Kingdom