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En fase 3-studie av VE303 for forebygging av tilbakevendende Clostridioides Difficile-infeksjon (RESTORATiVE303)

29. oktober 2026 oppdatert av: Vedanta Biosciences, Inc.

En randomisert, dobbeltblind, placebokontrollert fase 3-studie av VE303 for forebygging av tilbakevendende Clostridioides Difficile-infeksjon

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).

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

852

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Tilbaketrukket
        • Concord Repatriation General Hospital
      • Westmead, New South Wales, Australia, 2148
        • Tilbaketrukket
        • Westmead Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Tilbaketrukket
        • Monash Health
      • Parkville, Victoria, Australia, 3050
        • Tilbaketrukket
        • Melbourne Health
      • Anderlecht, Belgia, 1070
        • Rekruttering
        • Erasme University Hospital - Infectiology Department
        • Ta kontakt med:
      • Brussels, Belgia, 1200
        • Rekruttering
        • Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc
        • Ta kontakt med:
      • Ghent, Belgia, 9000
        • Rekruttering
        • Universitair Ziekenhuis Gent
        • Ta kontakt med:
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasil, 30150-221
        • Aktiv, ikke rekrutterende
        • CCIH - Consultoria em Controle de Infecção Hospitalar Ltda
    • Paraná
      • Curitiba, Paraná, Brasil, 80810-040
        • Rekruttering
        • Hospital Nossa Senhora das Graças
        • Ta kontakt med:
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brasil, 59025-050
        • Rekruttering
        • CPCLIN - Centro de Estudos e Pesquisas em Molestias Infecciosas - Pesquisa Clínica
        • Ta kontakt med:
    • Rio Grande do Sul
      • Caxias do Sul, Rio Grande do Sul, Brasil, 95070-561
        • Aktiv, ikke rekrutterende
        • Fundacao Universidade de Caxias do Sul - Hospital Geral de Caxias do Sul
      • Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
        • Rekruttering
        • Hospital de Clinicas de Porto Alegre - UFRGS
        • Ta kontakt med:
      • Porto Alegre, Rio Grande do Sul, Brasil, 90880-480
        • Aktiv, ikke rekrutterende
        • Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa
    • São Paulo
      • São Paulo, São Paulo, Brasil, 01323-903
        • Rekruttering
        • Hospital Alemao Oswaldo Cruz
        • Ta kontakt med:
      • Burgas, Bulgaria, 8000
        • Tilbaketrukket
        • UMHAT Burgas AD
      • Gorna Oryahovitsa, Bulgaria, 5100
        • Aktiv, ikke rekrutterende
        • Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
      • Lom, Bulgaria, 3600
        • Tilbaketrukket
        • Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOOD
      • Plovdiv, Bulgaria, 4003
        • Tilbaketrukket
        • Medicinski centar Hipokrat-N EOOD
      • Sliven, Bulgaria, 8800
        • Tilbaketrukket
        • MHAT Dr.Ivan Seliminski - Sliven Ltd.
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1407
        • Tilbaketrukket
        • Medical Center Excelsior OOD, Base 1
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
      • Edmonton, Alberta, Canada, T6G 2X8
      • Red Deer, Alberta, Canada, T4P 1K4
        • Rekruttering
        • CaRe Clinic
        • Ta kontakt med:
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Rekruttering
        • Vancouver Coastal Health Research Institute Clinical Research Unit
        • Ta kontakt med:
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 4B7
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B3V6
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Rekruttering
        • Research St. Josephs Hamilton
        • Ta kontakt med:
      • London, Ontario, Canada, N6A 4V2
      • Scarborough Village, Ontario, Canada, M1P 2T7
        • Tilbaketrukket
        • Viable Clinical Research Corporation
      • Toronto, Ontario, Canada, M5G 1L7
        • Rekruttering
        • University Health Network
        • Ta kontakt med:
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7Y8
        • Rekruttering
        • INTERMED groupe santé
        • Ta kontakt med:
      • Québec, Quebec, Canada, G1V 4G2
    • Central Jutland
      • Aarhus, Central Jutland, Danmark, 8200
        • Rekruttering
        • Aarhus University Hospital
        • Ta kontakt med:
    • Alabama
      • Huntsville, Alabama, Forente stater, 35801
        • Rekruttering
        • Metro Infectious Disease Consultants
        • Ta kontakt med:
    • Arizona
      • Chandler, Arizona, Forente stater, 85224
        • Tilbaketrukket
        • Advanced Gastroenterology, P.C.
      • Phoenix, Arizona, Forente stater, 85054
        • Tilbaketrukket
        • Mayo Clinic Hospital
      • Sun City, Arizona, Forente stater, 85351
    • California
      • Apple Valley, California, Forente stater, 92307
        • Tilbaketrukket
        • Om Research, LLC
      • Culver City, California, Forente stater, 90230
        • Rekruttering
        • Science 37 Inc (Remote/Home option)
        • Ta kontakt med:
      • Los Angeles, California, Forente stater, 90027
        • Rekruttering
        • Children's Hospital of Los Angeles
        • Ta kontakt med:
      • San Diego, California, Forente stater, 92161
        • Rekruttering
        • VA San Diego Healthcare System
        • Ta kontakt med:
      • San Dimas, California, Forente stater, 91773
        • Tilbaketrukket
        • North America Research Institute
      • Thousand Oaks, California, Forente stater, 91360
      • Torrance, California, Forente stater, 90502
        • Rekruttering
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
        • Ta kontakt med:
    • Connecticut
      • Bristol, Connecticut, Forente stater, 06010
        • Rekruttering
        • Connecticut Clinical Research Institute
        • Ta kontakt med:
      • Hamden, Connecticut, Forente stater, 06518
        • Rekruttering
        • Medical Research Center of Connecticut
        • Ta kontakt med:
      • Hartford, Connecticut, Forente stater, 06102
        • Tilbaketrukket
        • Hartford Hospital
    • Florida
      • Clearwater, Florida, Forente stater, 33756
        • Rekruttering
        • Gastro Florida
        • Ta kontakt med:
        • Ta kontakt med:
      • Fort Lauderdale, Florida, Forente stater, 33308
        • Rekruttering
        • Proactive Clinical Research, LLC
        • Ta kontakt med:
      • Jacksonville, Florida, Forente stater, 32256
        • Rekruttering
        • Encore Borland-Groover Clinical Research
        • Ta kontakt med:
      • Naples, Florida, Forente stater, 34102
      • Port Orange, Florida, Forente stater, 32127
        • Rekruttering
        • Advanced Medical Research Center
        • Ta kontakt med:
      • Saint Cloud, Florida, Forente stater, 34769
      • Tampa, Florida, Forente stater, 33614
        • Rekruttering
        • International Center for Research
        • Ta kontakt med:
      • Tampa, Florida, Forente stater, 33612
        • Rekruttering
        • James A. Haley Veterans' Hospital
        • Ta kontakt med:
    • Georgia
      • Athens, Georgia, Forente stater, 30607
      • Atlanta, Georgia, Forente stater, 30308
      • Decatur, Georgia, Forente stater, 30033
        • Rekruttering
        • Metro Infectious Disease Consultants
        • Ta kontakt med:
      • La Grange, Georgia, Forente stater, 30240
        • Tilbaketrukket
        • Regional Infectious Diseases and Infusion Center, Inc.
      • Marietta, Georgia, Forente stater, 30060
        • Rekruttering
        • Gastrointestinal Specialists of Georgia
        • Ta kontakt med:
    • Idaho
      • Idaho Falls, Idaho, Forente stater, 83404
        • Rekruttering
        • Snake River Research, PLLC
        • Ta kontakt med:
    • Illinois
      • Burr Ridge, Illinois, Forente stater, 60527
      • Evanston, Illinois, Forente stater, 60201
        • Tilbaketrukket
        • NorthShore University Health System - Evanston Hospital
      • Gurnee, Illinois, Forente stater, 60031
      • Island Lake, Illinois, Forente stater, 60042
        • Tilbaketrukket
        • Innovative Clinical Research Center, LLC (ICRC)
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Rekruttering
        • Indiana University Health University Hospital
        • Ta kontakt med:
        • Ta kontakt med:
      • New Albany, Indiana, Forente stater, 47150
        • Rekruttering
        • Gastroenterology Health Partners
        • Ta kontakt med:
      • Newburgh, Indiana, Forente stater, 47630
        • Tilbaketrukket
        • Deaconess GI Specialty Center
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
      • Wichita, Kansas, Forente stater, 67211
        • Tilbaketrukket
        • IDC Clinical Research, LLC
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40218
        • Rekruttering
        • Gastroenterology Health Partners
        • Ta kontakt med:
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70121
        • Rekruttering
        • Ochsner Clinic Foundation
        • Ta kontakt med:
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Aktiv, ikke rekrutterende
        • Johns Hopkins Hospital
      • Chevy Chase, Maryland, Forente stater, 20815
        • Rekruttering
        • MGG Group Co., Inc., Chevy Chase Clinical Research
        • Ta kontakt med:
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Rekruttering
        • Brigham and Women's Hospital
        • Ta kontakt med:
      • Boston, Massachusetts, Forente stater, 02114
        • Rekruttering
        • Massachusetts General Hospital
        • Ta kontakt med:
      • Boston, Massachusetts, Forente stater, 02111
        • Tilbaketrukket
        • Tufts Medical Center
      • Newton, Massachusetts, Forente stater, 02462
        • Tilbaketrukket
        • Newton-Wellesley Hospital
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48105
        • Rekruttering
        • LTC Charles S. Kettles VA Medical Center
        • Ta kontakt med:
      • Detroit, Michigan, Forente stater, 48202
        • Rekruttering
        • Henry Ford Health
        • Ta kontakt med:
      • Royal Oak, Michigan, Forente stater, 48073
        • Rekruttering
        • Corewell Health William Beaumont University Hospital
        • Ta kontakt med:
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • Rekruttering
        • University of Minnesota Medical Center
        • Ta kontakt med:
      • Plymouth, Minnesota, Forente stater, 55446
        • Tilbaketrukket
        • MNGI Digestive Health, PA
      • Rochester, Minnesota, Forente stater, 55905
    • Mississippi
      • Southaven, Mississippi, Forente stater, 38671
        • Tilbaketrukket
        • Delta Gastroenterology and Endoscopy Center
    • Missouri
      • Columbia, Missouri, Forente stater, 65212
        • Tilbaketrukket
        • University of Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Rekruttering
        • Washington University School of Medicine
        • Ta kontakt med:
      • Weldon Spring, Missouri, Forente stater, 63304
    • New Jersey
      • New Brunswick, New Jersey, Forente stater, 08901
        • Rekruttering
        • Rutgers Robert Wood Johnson Medical School
        • Ta kontakt med:
      • Somers Point, New Jersey, Forente stater, 08244
        • Rekruttering
        • South Jersey Infectious Disease
        • Ta kontakt med:
    • New York
      • Manhasset, New York, Forente stater, 11030
      • New York, New York, Forente stater, 10016
      • New York, New York, Forente stater, 10021
        • Aktiv, ikke rekrutterende
        • New York Presbyterian Hospital
      • New York, New York, Forente stater, 10279
        • Tilbaketrukket
        • Manhattan Clinical Research, LLC
      • Syracuse, New York, Forente stater, 13210
        • Avsluttet
        • Syracuse VA Medical Center
      • The Bronx, New York, Forente stater, 10467
        • Avsluttet
        • Montefiore Medical Center
    • Ohio
      • Toledo, Ohio, Forente stater, 43617
        • Tilbaketrukket
        • Toledo Institute of Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Tilbaketrukket
        • Oklahoma City Veterans Affairs Healthcare System
    • Pennsylvania
      • Harrisburg, Pennsylvania, Forente stater, 17110
        • Rekruttering
        • Susquehanna Research Group - Gastroenterology
        • Ta kontakt med:
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Rekruttering
        • Children's Hospital of Philadelphia
        • Ta kontakt med:
      • Sayre, Pennsylvania, Forente stater, 18840
        • Tilbaketrukket
        • Guthrie Medical Group, PC
      • Uniontown, Pennsylvania, Forente stater, 15401
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Aktiv, ikke rekrutterende
        • Medical University of South Carolina
      • Charleston, South Carolina, Forente stater, 29401
        • Tilbaketrukket
        • Ralph H. Johnson VA Health Care System
      • Charleston, South Carolina, Forente stater, 29414
        • Tilbaketrukket
        • Lowcountry Infectious Diseases, P.A.
    • Tennessee
      • Cordova, Tennessee, Forente stater, 38018
        • Rekruttering
        • Gastro One Research
        • Ta kontakt med:
      • Nashville, Tennessee, Forente stater, 37232
        • Rekruttering
        • Vanderbilt University Medical Center
        • Ta kontakt med:
    • Texas
      • Cedar Park, Texas, Forente stater, 78613
      • Dallas, Texas, Forente stater, 75246
        • Aktiv, ikke rekrutterende
        • North Texas Infectious Disease Consultants, P.A.
      • Houston, Texas, Forente stater, 77204
        • Tilbaketrukket
        • University of Houston College of Pharmacy
      • Katy, Texas, Forente stater, 77494
        • Tilbaketrukket
        • BioStar Clinical Research
      • Lubbock, Texas, Forente stater, 79410
      • Sugar Land, Texas, Forente stater, 77478
        • Tilbaketrukket
        • Simcare Medical Research, LLC
    • Virginia
      • Richmond, Virginia, Forente stater, 23229
    • Washington
      • Seattle, Washington, Forente stater, 98101
        • Aktiv, ikke rekrutterende
        • Virginia Mason Medical Center
      • Seattle, Washington, Forente stater, 98101
        • Tilbaketrukket
        • Seattle Infectious Disease Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53207
        • Rekruttering
        • Wisconsin Center for Advanced Research
        • Ta kontakt med:
      • Tours, Frankrike, 37044
        • Rekruttering
        • Chru De Tours
        • Ta kontakt med:
    • Auvergne-Rhône-Alpes
      • Les Paris, Auvergne-Rhône-Alpes, Frankrike, 75014
        • Aktiv, ikke rekrutterende
        • Hospital St. Joseph
    • Franche-Comté
      • Dijon, Franche-Comté, Frankrike, 21079
    • Grand Est
      • Paris, Grand Est, Frankrike, 51092 Reims Cedex
        • Rekruttering
        • Centre Hospitalier Universitaire (CHU) de Reims - Hopital Robert Debre
        • Ta kontakt med:
    • Hauts-de-France
      • Bordeaux Cedex, Hauts-de-France, Frankrike, 33075
        • Aktiv, ikke rekrutterende
        • CHU Bordeaux - Hopital Saint Andre Service de medecine interne et maladies infectieuses
    • Hauts-de-Seine
      • Garches, Hauts-de-Seine, Frankrike, 92380
        • Aktiv, ikke rekrutterende
        • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Ile-de-France Ouest - Raymond-Poincare
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, Frankrike, 44093
        • Rekruttering
        • CHU de Nantes - Hôtel Dieu
        • Ta kontakt med:
    • Paris
      • Paris, Paris, Frankrike, 75018
        • Rekruttering
        • Assistance Publique Hôpitaux de Paris Hôpital Bichat- Claude Bernard - Département des maladies infectieuses et tropicales
        • Ta kontakt med:
    • Rhone
      • Lyon, Rhone, Frankrike, 69004
        • Rekruttering
        • Hôpital De La Croix Rousse - Gastroenterology
        • Ta kontakt med:
      • Tbilisi, Georgia, 0159
        • Rekruttering
        • LTD "Emergency Cardiology Center named by Acad.G.Chapidze"
        • Ta kontakt med:
    • K'alak'i T'bilisi
      • Tbilisi, K'alak'i T'bilisi, Georgia, 0112
        • Rekruttering
        • ISR-GEO Med Res Clin Healthycore
        • Ta kontakt med:
      • Tbilisi, K'alak'i T'bilisi, Georgia, 0160
        • Rekruttering
        • LTD "Academician Vakhtang Bochorishvili Clinic"
        • Ta kontakt med:
      • Tbilisi, K'alak'i T'bilisi, Georgia, 0160
        • Rekruttering
        • LTD "Aversi Clinic"
        • Ta kontakt med:
    • Dublin
      • Dublin, Dublin, Irland, 9
        • Tilbaketrukket
        • Royal College of Surgeons in Ireland - Beaumont Hospital - Education and Research Centre
    • Louth
      • Drogheda, Louth, Irland, A92 VW28
        • Tilbaketrukket
        • Our Lady of Lourdes Hospital
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Aktiv, ikke rekrutterende
        • Rabin Medical Center - Beilinson Hospital
      • Tel Aviv, Central District, Israel, 64239
        • Rekruttering
        • Tel Aviv Sourasky Medical Center
        • Ta kontakt med:
      • Tsrifin, Central District, Israel, 7030000
        • Rekruttering
        • Shamir Medical Center (Assaf Harofeh)
        • Ta kontakt med:
    • Haifa District
      • Haifa, Haifa District, Israel, 34406
        • Aktiv, ikke rekrutterende
        • Carmel Medical Center
    • Haifa North
      • Hadera, Haifa North, Israel, 3810101
        • Aktiv, ikke rekrutterende
        • Hillel Yaffe MC, Clinical Research Unit
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91120
        • Tilbaketrukket
        • Hadassah Medical Centre
    • Southern District
      • Ashkelon, Southern District, Israel, 7830604
        • Rekruttering
        • The Barzilai Medical Center
        • Ta kontakt med:
      • Pisa, Italia, 56124
        • Rekruttering
        • AOU Pisana - Stabilimento di Cisanello
        • Ta kontakt med:
      • Roma, Italia, 00186
        • Rekruttering
        • Ospedale Isola Tiberina Gemelli Isola
        • Ta kontakt med:
    • Alessandria
      • Alessandria, Alessandria, Italia, 15121
        • Rekruttering
        • AO Nazionale SS. Antonio e Biagio e C. Arrigo
        • Ta kontakt med:
    • Lombardy
      • Lecco, Lombardy, Italia, 23900
        • Rekruttering
        • PO A. Manzoni di Lecco, ASST Lecco
        • Ta kontakt med:
    • Milano
      • Milan, Milano, Italia, 20157
        • Aktiv, ikke rekrutterende
        • Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
    • Monza E Brianza
      • Monza, Monza E Brianza, Italia, 20900
        • Aktiv, ikke rekrutterende
        • Fondazione IRCCS San Gerardo dei Tintori
    • Napoli
      • Naples, Napoli, Italia, 80131
        • Rekruttering
        • Azienda Ospedaliera Universitaria Federico II
        • Ta kontakt med:
    • Pavia
      • Pavia, Pavia, Italia, 27100
        • Rekruttering
        • IRCCS Policlinico San Matteo, Università degli studi di Pavia
        • Ta kontakt med:
    • Reggio Emilia
      • Modena, Reggio Emilia, Italia, 41124
        • Rekruttering
        • Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena - Malattie Infettive E Tropicali
        • Ta kontakt med:
    • Roma
      • Roma, Roma, Italia, 00165
        • Aktiv, ikke rekrutterende
        • Osp. Pediatrico Bambino Gesù, IRCCS
    • Veneto
      • Vittorio Veneto, Veneto, Italia, 31029
        • Aktiv, ikke rekrutterende
        • Presidio Ospedaliero di Vittorio Veneto
    • Aguascalientes
      • Aguascalientes, Aguascalientes, Mexico, 20116
        • Rekruttering
        • Centro de Investigacion Medica Aguascalientes
        • Ta kontakt med:
      • Aguascalientes, Aguascalientes, Mexico, 20230
        • Rekruttering
        • Hospital Cardiologica Aguascalientes - Investigacion
        • Ta kontakt med:
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • Rekruttering
        • JM Research S.C - Pediatrics
        • Ta kontakt med:
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Rekruttering
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Infectious Diseases
        • Ta kontakt med:
    • Veracruz
      • Veracruz, Veracruz, Mexico, 91900
        • Aktiv, ikke rekrutterende
        • FAICIC S de RL de C.V. - Gastroenterology
      • Utrecht, Nederland, 3584 CX
        • Rekruttering
        • Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
        • Ta kontakt med:
    • South Holland
      • Leiden, South Holland, Nederland, 2333 ZA
        • Rekruttering
        • Leids Universitair Medisch Centrum (LUMC)
        • Ta kontakt med:
        • Ta kontakt med:
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 03-580
        • Tilbaketrukket
        • NZOZ VIVAMED Jadwiga Miecz
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Polen, 40-600
        • Tilbaketrukket
        • Gyncentrum sp. z o.o.
      • Braga, Portugal, 4710-243
        • Tilbaketrukket
        • CCAB Centro Clinico Academico Braga Associacao - ULS Braga
      • Guarda, Portugal, 6301-858
        • Tilbaketrukket
        • Unidade Local de Saúde da Guarda (ULSG)
      • Porto, Portugal, 4050-011
        • Tilbaketrukket
        • Unidade Local De Saude De Santo Antonio E.P.E.
      • Vila Nova de Gaia, Portugal, 4434-502
        • Tilbaketrukket
        • Unidade Local De Saude De Gaia/Espinho E.P.E.
    • Braga District
      • Guimarães, Braga District, Portugal, 4835-044
        • Tilbaketrukket
        • Unidade Local De Saude Do Alto Ave E.P.E.
    • Coimbra District
      • Coimbra, Coimbra District, Portugal, 3004-591
        • Tilbaketrukket
        • Unidade Local De Saude De Coimbra E.P.E.
    • Lisbon District
      • Almada, Lisbon District, Portugal, 2805-267
        • Tilbaketrukket
        • Unidade Local De Saude De Almada-Seixal E.P.E.
    • Bucharest
      • Bucharest, Bucharest, Romania, 021105
        • Rekruttering
        • Institutul de Boli Infecțioase Prof Dr Matei Bals - Infectious diseases V
        • Ta kontakt med:
      • Bucharest, Bucharest, Romania, 030303
        • Rekruttering
        • Spitalul Clinic de Boli Infectioase si Tropicale Dr Victor Babes
        • Ta kontakt med:
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400348
        • Aktiv, ikke rekrutterende
        • Spitalul Clinic de Boli Infectioase Cluj-Napoca
    • Dolj
      • Craiova, Dolj, Romania, 200073
        • Tilbaketrukket
        • Centrul Medical Renasterea
    • Iaşi
      • Iași, Iaşi, Romania, 700116
        • Rekruttering
        • Spitalul Clinic de Boli Infectioase Sfanta Parascheva Iasi - Infectious diseases I
        • Ta kontakt med:
    • Timiș County
      • Timișoara, Timiș County, Romania, 300723
        • Tilbaketrukket
        • Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
      • A Coruña, Spania, 15006
        • Rekruttering
        • Complexo Hospitalario Universitario A Coruña
        • Ta kontakt med:
      • Alicante, Spania, 03010
        • Rekruttering
        • Hospital General Universitario Dr Balmis
        • Ta kontakt med:
      • Barcelona, Spania, 08036
        • Rekruttering
        • Hospital Clinic de Barcelona
        • Ta kontakt med:
      • Barcelona, Spania, 08041
        • Rekruttering
        • Hospital de La Santa Creu i Sant Pau
        • Ta kontakt med:
      • Córdoba, Spania, 14004
        • Rekruttering
        • Hospital Universitario Reina Sofia
        • Ta kontakt med:
      • Madrid, Spania, 28034
        • Rekruttering
        • Hospital Universitario Ramón y Cajal
        • Ta kontakt med:
      • Seville, Spania, 41009
        • Rekruttering
        • Hospital Universitario Virgen De La Macarena
        • Ta kontakt med:
    • Barcelona
      • Badalona, Barcelona, Spania, 08916
        • Rekruttering
        • Hospital Universitari Germans Trias i Pujol
        • Ta kontakt med:
      • Barcelona, Barcelona, Spania, 08907
        • Rekruttering
        • Hospital Universitario de Bellvitge
        • Ta kontakt med:
      • Terrassa, Barcelona, Spania, 08221
        • Aktiv, ikke rekrutterende
        • Hospital Universitario Mutua de Terrassa
    • Guipúzcoa
      • San Sebastián, Guipúzcoa, Spania, 20014
    • Madrid
      • Madrid, Madrid, Spania, 28007
      • Madrid, Madrid, Spania, 28046
        • Rekruttering
        • Hospital Universitario La Paz - UCICEC
        • Ta kontakt med:
      • Majadahonda, Madrid, Spania, 28222
        • Rekruttering
        • Hospital Universitario Puerta De Hierro Majadahonda
        • Ta kontakt med:
    • Sevilla
      • Seville, Sevilla, Spania, 41014
        • Rekruttering
        • Hospital Universitario Virgen Macarena
        • Ta kontakt med:
      • Bournemouth, Storbritannia, BH7 7DW
        • Tilbaketrukket
        • The Royal Bournemouth Hospital
      • Bristol, Storbritannia, BS10 5NB
        • Rekruttering
        • North Bristol NHS Trust - Southmead Hospital, Clinical Research Centre
        • Ta kontakt med:
      • Edinburgh, Storbritannia, EH4 2XU
        • Rekruttering
        • NHS Lothian - Western General Hospital
        • Ta kontakt med:
      • London, Storbritannia, NW3 2QG
        • Rekruttering
        • Royal Free London NHS Foundation Trust
        • Ta kontakt med:
      • London, Storbritannia, SE1 7EH
        • Rekruttering
        • St.Thomas' Hospital
        • Ta kontakt med:
      • Sheffield, Storbritannia, S5 7AU
        • Rekruttering
        • Northern General Hospital
        • Ta kontakt med:
      • Swansea, Storbritannia, SA6 6NL
    • Devon
      • Exeter, Devon, Storbritannia, EX2 5DW
        • Tilbaketrukket
        • Royal Devon University Healthcare NHS Trust
    • Gangwon-do
      • Wŏnju, Gangwon-do, Sør -Korea, 26426
        • Aktiv, ikke rekrutterende
        • Yonsei University, Wonju Severance Christian Hospital
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Sør -Korea, 06351
        • Rekruttering
        • Samsung Medical Center
        • Ta kontakt med:
      • Seoul, Seoul Teugbyeolsi, Sør -Korea, 07441
        • Rekruttering
        • Hallym University Kangnam Sacred Heart Hospital
        • Ta kontakt med:
      • Seoul, Seoul Teugbyeolsi, Sør -Korea, 06591
        • Rekruttering
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Ta kontakt med:
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Taiwan, 80756
        • Rekruttering
        • KMU Chung-Ho Memorial Hospital
        • Ta kontakt med:
    • Taichung
      • Taichung, Taichung, Taiwan, 404327
        • Rekruttering
        • China Medical University Hospital - Infectious
        • Ta kontakt med:
    • Taoyuan
      • Taoyuan, Taoyuan, Taiwan, 333423
        • Rekruttering
        • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
        • Ta kontakt med:
      • Kyjov, Tsjekkia, 697 01
        • Tilbaketrukket
        • Nemocnice Kyjov, p.o.
      • Ostrava-Poruba, Tsjekkia, 708 52
        • Tilbaketrukket
        • Fakultni Nemocnice Ostrava
    • Brno-město
      • Brno, Brno-město, Tsjekkia, 625 00
        • Tilbaketrukket
        • Fakultni nemocnice Brno
    • Hesse
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Tyskland, 50937
        • Rekruttering
        • University Hospital Cologne AöR - Klinik I für Innere Medizin
        • Ta kontakt med:
    • State of Berlin
      • Berlin, State of Berlin, Tyskland, 12157
        • Rekruttering
        • Epimed GmbH
        • Ta kontakt med:
      • Budapest, Ungarn, 1088
        • Aktiv, ikke rekrutterende
        • Semmelweis Egyetem
      • Nyíregyháza, Ungarn, 4400
        • Tilbaketrukket
        • Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház Nyíregyházi Jósa András Tagkórház
    • Bekes County
      • Békéscsaba, Bekes County, Ungarn, 5600
        • Tilbaketrukket
        • Bekes Varmegyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
    • Csongrád megye
      • Szeged, Csongrád megye, Ungarn, H-6725
        • Tilbaketrukket
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. sz. Belgyogyaszati Klinika
    • Komárom-Esztergom
      • Tatabánya, Komárom-Esztergom, Ungarn, 2800
        • Aktiv, ikke rekrutterende
        • Komárom-Esztergom Vármegyei Szent Borbála Kórház

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population):

  • Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months

Key Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population):

  • Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI

  • OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors:

    1. Age ≥ 65 years
    2. Kidney dysfunction, defined as estimated creatinine clearance < 60 mL/min/1.73 m^2 at the time of the qualifying CDI episode
    3. History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study
    4. History of a prior CDI episode between 6 and 12 months prior to enrollment
    5. Immunosuppression due to an underlying disease or its treatment
    6. Has undergone solid organ or hematopoietic stem cell transplantation

Key Inclusion Criteria (For enrollment in Stage 1 or 2):

  • The qualifying episode of CDI must meet all the following criteria:

    1. New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days
    2. CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI
    3. Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as enzyme immunoassay (EIA) for toxin A/B and glutamate dehydrogenase (GDH) with polymerase chain reaction (PCR) reflex testing for discordant EIA/GDH results, performed at either a local laboratory or the central laboratory
    4. Diarrhea considered unlikely to have another etiology
  • Prior to receiving any study medication, the participant should:

    1. Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible for decentralized participants to be randomized during SoC antibiotic administration.
    2. Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, < 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days
  • Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing

  • Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization

Key Exclusion Criteria (For both Stage 1 and Stage 2):

  • History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI
  • Known or suspected toxic megacolon or small bowel ileus at the time of randomization
  • History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis
  • Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode
  • Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug
  • Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study)
  • Probiotics, whether characterized as a dietary/food supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. (Note: consumption of food-based products such as yogurt, kombucha, and kefir are permitted.)
  • Absolute neutrophil count (ANC) of < 0.5 ×10^9 cells/L on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC < 1.0 × 10^9 cells/L

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

VE303 is a live biotherapeutic product (LBP) consisting of 8 clonally derived, nonpathogenic, nontoxigenic, commensal bacteria strains manufactured under Good Manufacturing Practices (GMP) conditions.

Placebo komparator: 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.

Placebo capsules contain microcrystalline cellulose. Placebo capsules are visually identical to and not discernible from VE303 capsules. Placebo capsules will not contain any VE303 drug product.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
CDI Recurrence Rate at Week 8
Tidsramme: 8 weeks

Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.

8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. mai 2024

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. oktober 2027

Datoer for studieregistrering

Først innsendt

23. januar 2024

Først innsendt som oppfylte QC-kriteriene

23. januar 2024

Først lagt ut (Faktiske)

1. februar 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. oktober 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • VE303-003
  • 75A50120C00177 (Annet stipend/finansieringsnummer: Biomedical Advanced Research and Development Authority)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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