VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Start Date
5/20/2024
Completion Date
10/1/2027
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).
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
VE303
Placebo
Conditions
Locations
Metro Infectious Disease Consultants
Huntsville, Alabama 35801
United States
Advanced Gastroenterology, P.C.
Chandler, Arizona 85224
United States
Mayo Clinic Hospital
Phoenix, Arizona 85054
United States
GI Alliance
Sun City, Arizona 85351
United States
Om Research, LLC
Apple Valley, California 92307
United States
Science 37 Inc (Remote/Home option)
Culver City, California 90230
United States
Children's Hospital of Los Angeles
Los Angeles, California 90027
United States
VA San Diego Healthcare System
San Diego, California 92161
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
Connecticut Clinical Research Institute
Bristol, Connecticut 06010
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.
La Grange, 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
GI Alliance
Gurnee, Illinois 60031
United States
Innovative Clinical Research Center, LLC (ICRC)
Island Lake, Illinois 60042
United States
Indiana University Health University Hospital
Indianapolis, Indiana 46202
United States
Gastroenterology Health Partners
New Albany, Indiana 47150
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
Gastroenterology Health Partners
Louisville, Kentucky 40218
United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
United States
Tufts Medical Center
Boston, Massachusetts 02111
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Newton-Wellesley Hospital
Newton, Massachusetts 02462
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
St 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
Northwell Health Division of Infectious Diseases
Manhasset, New York 11030
United States
NYU Grossman School of Medicine
New York, New York 10016
United States
New York Presbyterian Hospital
New York, New York 10021
United States
Manhattan Clinical Research, LLC
New York, New York 10279
United States
Syracuse VA Medical Center
Syracuse, New York 13210
United States
Montefiore Medical Center
The Bronx, New York 10467
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
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Guthrie Medical Group, PC
Sayre, Pennsylvania 18840
United States
Frontier Clinical Research
Uniontown, Pennsylvania 15401
United States
Ralph H. Johnson VA Health Care System
Charleston, South Carolina 29401
United States
Lowcountry Infectious Diseases, P.A.
Charleston, South Carolina 29414
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Gastro One Research
Cordova, Tennessee 38018
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
GI Alliance
Cedar Park, Texas 78613
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
GI Alliance
Lubbock, Texas 79410
United States
Simcare Medical Research, LLC
Sugar Land, Texas 77478
United States
GI Alliance
Richmond, Virginia 23229
United States
Seattle Infectious Disease Clinic
Seattle, Washington 98101
United States
Virginia Mason Medical Center
Seattle, Washington 98101
United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin 53207
United States
Concord Repatriation General Hospital
Concord, New South Wales 2139
Australia
Westmead Hospital
Westmead, New South Wales 2148
Australia
Monash Health
Clayton, Victoria 3168
Australia
Melbourne Health
Parkville, Victoria 3050
Australia
Erasme University Hospital - Infectiology Department
Anderlecht, 1070
Belgium
Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
Universitair Ziekenhuis Gent
Ghent, 9000
Belgium
CCIH - Consultoria em Controle de Infecção Hospitalar Ltda
Belo Horizonte, Minas Gerais 30150-221
Brazil
Hospital Nossa Senhora das Graças
Curitiba, Paraná 80810-040
Brazil
CPCLIN - Centro de Estudos e Pesquisas em Molestias Infecciosas - Pesquisa Clínica
Natal, Rio Grande do Norte 59025-050
Brazil
Fundacao Universidade de Caxias do Sul - Hospital Geral de Caxias do Sul
Caxias do Sul, Rio Grande do Sul 95070-561
Brazil
Hospital de Clinicas de Porto Alegre - UFRGS
Porto Alegre, Rio Grande do Sul 90035-903
Brazil
Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa
Porto Alegre, Rio Grande do Sul 90880-480
Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo 01323-903
Brazil
Medical Center Excelsior OOD, Base 1
Sofia, Sofia-Grad 1407
Bulgaria
UMHAT Burgas AD
Burgas, 8000
Bulgaria
Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Gorna Oryahovitsa, 5100
Bulgaria
Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOOD
Lom, 3600
Bulgaria
Medicinski centar Hipokrat-N EOOD
Plovdiv, 4003
Bulgaria
MHAT Dr.Ivan Seliminski - Sliven Ltd.
Sliven, 8800
Bulgaria
Alberta Health Services (AHS) - Foothills Medical Centre
Calgary, Alberta T2N 2T9
Canada
University of Alberta
Edmonton, Alberta T6G 2X8
Canada
CaRe Clinic
Red Deer, Alberta T4P 1K4
Canada
Vancouver Coastal Health Research Institute Clinical Research Unit
Vancouver, British Columbia V5Z 1M9
Canada
The Moncton Hospital
Moncton, New Brunswick E1C 4B7
Canada
NL Health Services
St. John's, Newfoundland and Labrador A1B3V6
Canada
Research St. Josephs Hamilton
Hamilton, Ontario L8N 4A6
Canada
St. Joseph's Hospital - London
London, Ontario N6A 4V2
Canada
Viable Clinical Research Corporation
Scarborough Village, Ontario M1P 2T7
Canada
University Health Network
Toronto, Ontario M5G 1L7
Canada
INTERMED groupe santé
Chicoutimi, Quebec G7H 7Y8
Canada
Centre Hospitalier de l Universite Laval (CHUL)
Québec, Quebec G1V 4G2
Canada
Fakultni nemocnice Brno
Brno, Brno-město 625 00
Czechia
Nemocnice Kyjov, p.o.
Kyjov, 697 01
Czechia
Fakultni Nemocnice Ostrava
Ostrava-Poruba, 708 52
Czechia
Aarhus University Hospital
Aarhus, Central Jutland 8200
Denmark
Hospital St. Joseph
Les Paris, Auvergne-Rhône-Alpes 75014
France
Hôpital du Bocage
Dijon, Franche-Comté 21079
France
Centre Hospitalier Universitaire (CHU) de Reims - Hopital Robert Debre
Paris, Grand Est 51092 Reims Cedex
France
CHU Bordeaux - Hopital Saint Andre Service de medecine interne et maladies infectieuses
Bordeaux Cedex, Hauts-de-France 33075
France
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Ile-de-France Ouest - Raymond-Poincare
Garches, Hauts-de-Seine 92380
France
CHU de Nantes - Hôtel Dieu
Nantes, Loire-Atlantique 44093
France
Assistance Publique Hôpitaux de Paris Hôpital Bichat- Claude Bernard - Département des maladies infectieuses et tropicales
Paris, Paris 75018
France
Hôpital De La Croix Rousse - Gastroenterology
Lyon, Rhone 69004
France
Chru De Tours
Tours, 37044
France
ISR-GEO Med Res Clin Healthycore
Tbilisi, K'alak'i T'bilisi 0112
Georgia
LTD "Academician Vakhtang Bochorishvili Clinic"
Tbilisi, K'alak'i T'bilisi 0160
Georgia
LTD "Aversi Clinic"
Tbilisi, K'alak'i T'bilisi 0160
Georgia
LTD "Emergency Cardiology Center named by Acad.G.Chapidze"
Tbilisi, 0159
Georgia
University Hospital Frankfurt
Frankfurt am Main, Hesse 60590
Germany
University Hospital Cologne AöR - Klinik I für Innere Medizin
Cologne, North Rhine-Westphalia 50937
Germany
Epimed GmbH
Berlin, State of Berlin 12157
Germany
Bekes Varmegyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
Békéscsaba, Bekes County 5600
Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. sz. Belgyogyaszati Klinika
Szeged, Csongrád megye H-6725
Hungary
Komárom-Esztergom Vármegyei Szent Borbála Kórház
Tatabánya, Komárom-Esztergom 2800
Hungary
Semmelweis Egyetem
Budapest, 1088
Hungary
Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház Nyíregyházi Jósa András Tagkórház
Nyíregyháza, 4400
Hungary
Royal College of Surgeons in Ireland - Beaumont Hospital - Education and Research Centre
Dublin, Dublin 9
Ireland
Our Lady of Lourdes Hospital
Drogheda, Louth A92 VW28
Ireland
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Central District 4941492
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Central District 64239
Israel
Shamir Medical Center (Assaf Harofeh)
Ẕerifin, Central District 7030000
Israel
Carmel Medical Center
Haifa, Haifa District 34406
Israel
Hillel Yaffe MC, Clinical Research Unit
Hadera, Haifa North 3810101
Israel
Hadassah Medical Centre
Jerusalem, Jerusalem 91120
Israel
The Barzilai Medical Center
Ashkelon, Southern District 7830604
Israel
Rambam Health Care Campus
Haifa, 31096
Israel
The Chaim Sheba Medical Center
Tel Litwinsky, 5265601
Israel
AO Nazionale SS. Antonio e Biagio e C. Arrigo
Alessandria, Alessandria 15121
Italy
PO A. Manzoni di Lecco, ASST Lecco
Lecco, Lombardy 23900
Italy
Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
Milan, Milano 20157
Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza E Brianza 20900
Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Napoli 80131
Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavia
Pavia, Pavia 27100
Italy
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena - Malattie Infettive E Tropicali
Modena, Reggio Emilia 41124
Italy
Osp. Pediatrico Bambino Gesù, IRCCS
Roma, Roma 00165
Italy
Presidio Ospedaliero di Vittorio Veneto
Vittorio Veneto, Veneto 31029
Italy
AOU Pisana - Stabilimento di Cisanello
Pisa, 56124
Italy
Ospedale Isola Tiberina Gemelli Isola
Roma, 00186
Italy
Centro de Investigacion Medica Aguascalientes
Aguascalientes, Aguascalientes 20116
Mexico
Hospital Cardiologica Aguascalientes - Investigacion
Aguascalientes, Aguascalientes 20230
Mexico
JM Research S.C - Pediatrics
Cuernavaca, Morelos 62290
Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Infectious Diseases
Monterrey, Nuevo León 64460
Mexico
FAICIC S de RL de C.V. - Gastroenterology
Veracruz, Veracruz 91900
Mexico
Leids Universitair Medisch Centrum (LUMC)
Leiden, South Holland 2333 ZA
Netherlands
Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
Utrecht, 3584 CX
Netherlands
NZOZ VIVAMED Jadwiga Miecz
Warsaw, Masovian Voivodeship 03-580
Poland
Gyncentrum sp. z o.o.
Katowice, Silesian Voivodeship 40-600
Poland
Unidade Local De Saude Do Alto Ave E.P.E.
Guimarães, Braga District 4835-044
Portugal
Unidade Local De Saude De Coimbra E.P.E.
Coimbra, Coimbra District 3004-591
Portugal
Unidade Local De Saude De Almada-Seixal E.P.E.
Almada, Lisbon District 2805-267
Portugal
CCAB Centro Clinico Academico Braga Associacao - ULS Braga
Braga, 4710-243
Portugal
Unidade Local de Saúde da Guarda (ULSG)
Guarda, 6301-858
Portugal
Unidade Local De Saude De Santo Antonio E.P.E.
Porto, 4050-011
Portugal
Unidade Local De Saude De Gaia/Espinho E.P.E.
Vila Nova de Gaia, 4434-502
Portugal
Institutul de Boli Infecțioase Prof Dr Matei Bals - Infectious diseases V
Bucharest, Bucharest 021105
Romania
Spitalul Clinic de Boli Infectioase si Tropicale Dr Victor Babes
Bucharest, Bucharest 030303
Romania
Spitalul Clinic de Boli Infectioase Cluj-Napoca
Cluj-Napoca, Cluj 400348
Romania
Centrul Medical Renasterea
Craiova, Dolj 200073
Romania
Spitalul Clinic de Boli Infectioase Sfanta Parascheva Iasi - Infectious diseases I
Iași, Iaşi 700116
Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Timișoara, Timiș County 300723
Romania
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, Gangwon-do 26426
South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi 06351
South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi 06591
South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul Teugbyeolsi 07441
South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona 08916
Spain
Hospital Universitario de Bellvitge
Barcelona, Barcelona 08907
Spain
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona 08221
Spain
H. U. Donostia
San Sebastián, Guipúzcoa 20014
Spain
Gregorio Marañón University Hospital
Madrid, Madrid 28007
Spain
Hospital Universitario La Paz - UCICEC
Madrid, Madrid 28046
Spain
Hospital Universitario Puerta De Hierro Majadahonda
Majadahonda, Madrid 28222
Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla 41014
Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, 15006
Spain
Hospital General Universitario Dr Balmis
Alicante, 03010
Spain
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041
Spain
Hospital Universitario Reina Sofia
Córdoba, 14004
Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034
Spain
Hospital Universitario Virgen De La Macarena
Seville, 41009
Spain
KMU Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung 80756
Taiwan
China Medical University Hospital - Infectious
Taichung, Taichung 404327
Taiwan
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Taoyuan, Taoyuan 333423
Taiwan
Royal Devon University Healthcare NHS Trust
Exeter, Devon EX2 5DW
United Kingdom
The Royal Bournemouth Hospital
Bournemouth, BH7 7DW
United Kingdom
North Bristol NHS Trust - Southmead Hospital, Clinical Research Centre
Bristol, BS10 5NB
United Kingdom
NHS Lothian - Western General Hospital
Edinburgh, EH4 2XU
United Kingdom
Royal Free London NHS Foundation Trust
London, NW3 2QG
United Kingdom
St.Thomas' Hospital
London, SE1 7EH
United Kingdom
Northern General Hospital
Sheffield, S5 7AU
United Kingdom
Morriston Hospital
Swansea, SA6 6NL
United Kingdom