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Et fase 3-studie af VE303 til forebyggelse af tilbagevendende Clostridioides Difficile-infektion (RESTORATiVE303)

29. oktober 2026 opdateret af: Vedanta Biosciences, Inc.

Et randomiseret, dobbeltblindt, placebokontrolleret fase 3-studie af VE303 til forebyggelse af tilbagevendende Clostridioides Difficile-infektion

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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

852

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. maj 2024

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. oktober 2027

Datoer for studieregistrering

Først indsendt

23. januar 2024

Først indsendt, der opfyldte QC-kriterier

23. januar 2024

Først opslået (Faktiske)

1. februar 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .