Et fase 3-studie af VE303 til forebyggelse af tilbagevendende Clostridioides Difficile-infektion (RESTORATiVE303)
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
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Steven Shiff, MD
- Telefonnummer: 857-706-1427
- E-mail: Consortium02-ctinquiries@vedantabio.com
Undersøgelse Kontakt Backup
- Navn: Paul McGovern, MD
- Telefonnummer: 857-706-1427
- E-mail: Consortium02-ctinquiries@vedantabio.com
Studiesteder
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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
-
-
-
-
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Anderlecht, Belgien, 1070
- Rekruttering
- Erasme University Hospital - Infectiology Department
-
Kontakt:
- Odette Mukangenzi
- Telefonnummer: +32025558070
- E-mail: odette.mukangenzi@hubruxelles.be
-
Brussels, Belgien, 1200
- Rekruttering
- Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc
-
Kontakt:
- Celine D'Aoust
- Telefonnummer: +323227642190
- E-mail: celine.daoust@saintluc.uclouvain.be
-
Ghent, Belgien, 9000
- Rekruttering
- Universitair Ziekenhuis Gent
-
Kontakt:
- Els Caluwe
- Telefonnummer: +32093325414
- E-mail: els.caluwe@uzgent.be
-
-
-
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Minas Gerais
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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:
- Otavio Henrique Tomczak Paulichei
- Telefonnummer: +55 41999150238
- E-mail: otavio.cmsf@gmail.com
-
-
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:
- Sibele Araujo
- Telefonnummer: 55 84 99172-0060
- E-mail: sibelearaujo@cpclinrn.com.br
-
-
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:
- Taiane Vieira
- Telefonnummer: (51) 3359-6256
- E-mail: tavieira@hcpa.edu.br
-
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:
- Daniela Maia
- Telefonnummer: 551135491542
- E-mail: daniela.maia@haoc.com.br
-
-
-
-
-
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
- Rekruttering
- Alberta Health Services (AHS) - Foothills Medical Centre
-
Kontakt:
- Thomas Louie, MD
- Telefonnummer: 403-944-2038
- E-mail: thomas.louie@albertahealthservices.ca
-
Edmonton, Alberta, Canada, T6G 2X8
- Rekruttering
- University of Alberta
-
Kontakt:
- Rose Franz
- Telefonnummer: 780-248-1342
- E-mail: Rose.Franz@albertahealthservices.ca
-
Red Deer, Alberta, Canada, T4P 1K4
- Rekruttering
- CaRe Clinic
-
Kontakt:
- Kayla Tiessen
- Telefonnummer: 587-815-0803
- E-mail: kayla@careclinicrd.ca
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Rekruttering
- Vancouver Coastal Health Research Institute Clinical Research Unit
-
Kontakt:
- Ariel Huang
- Telefonnummer: 69697 604-875-4111
- E-mail: Ariel.huang@vch.ca
-
-
New Brunswick
-
Moncton, New Brunswick, Canada, E1C 4B7
- Rekruttering
- The Moncton Hospital
-
Kontakt:
- Chantal Houser
- Telefonnummer: 506-857-5669
- E-mail: chantal.houser@horizonnb.ca
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canada, A1B3V6
- Rekruttering
- NL Health Services
-
Kontakt:
- Marie Josephine Faye
- Telefonnummer: 709-777-2953
- E-mail: marie.faye@nlhealthservices.ca
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- Rekruttering
- Research St. Josephs Hamilton
-
Kontakt:
- Adam Weerdenburg
- Telefonnummer: 32553 905-522-1155
- E-mail: aweerden@stjosham.on.ca
-
London, Ontario, Canada, N6A 4V2
- Rekruttering
- St. Joseph's Hospital - London
-
Kontakt:
- Mahnaz Kazi
- Telefonnummer: 519-646-6100
- E-mail: Mahnaz.Kazi@sjhc.london.on.ca
-
Scarborough Village, Ontario, Canada, M1P 2T7
- Trukket tilbage
- Viable Clinical Research Corporation
-
Toronto, Ontario, Canada, M5G 1L7
- Rekruttering
- University Health Network
-
Kontakt:
- Maria Kulikova
- Telefonnummer: 647-469-7457
- E-mail: Maria.kulikova@uhn.ca
-
-
Quebec
-
Chicoutimi, Quebec, Canada, G7H 7Y8
- Rekruttering
- INTERMED groupe santé
-
Kontakt:
- Nancy Lavoie
- Telefonnummer: 418-602-6620
- E-mail: n.lavoie@intermedgs.ca
-
Québec, Quebec, Canada, G1V 4G2
- Rekruttering
- Centre Hospitalier de l Universite Laval (CHUL)
-
Kontakt:
- Isabelle Chabot
- Telefonnummer: 47778 418-525-4444
- E-mail: isabelle.chabot@crchudequebec.ulaval.ca
-
-
-
-
Central Jutland
-
Aarhus, Central Jutland, Danmark, 8200
- Rekruttering
- Aarhus University Hospital
-
Kontakt:
- Toto Nairn
- Telefonnummer: +4551504815
- E-mail: catrmark@rm.dk
-
-
-
-
-
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:
- Kirstie Bradburn
- Telefonnummer: +4401174148102
- E-mail: Kirstie.Bradburn@nbt.nhs.uk
-
Edinburgh, Det Forenede Kongerige, EH4 2XU
- Rekruttering
- NHS Lothian - Western General Hospital
-
Kontakt:
- Amy Shepherd
- Telefonnummer: +4401315372840
- E-mail: Amy.shepherd@nhs.scot
-
London, Det Forenede Kongerige, NW3 2QG
- Rekruttering
- Royal Free London NHS Foundation Trust
-
Kontakt:
- Audrey Abdul
- Telefonnummer: +442074726446
- E-mail: Audrey.abdul@nhs.net
-
London, Det Forenede Kongerige, SE1 7EH
- Rekruttering
- St.Thomas' Hospital
-
Kontakt:
- Alieza Rara
- Telefonnummer: 53339 +4402071887188
- E-mail: Alieza.Rara@gstt.nhs.uk
-
Sheffield, Det Forenede Kongerige, S5 7AU
- Rekruttering
- Northern General Hospital
-
Kontakt:
- Priya Lata
- Telefonnummer: +4401142715779
- E-mail: priya.lata@nhs.net
-
Swansea, Det Forenede Kongerige, SA6 6NL
- Rekruttering
- Morriston Hospital
-
Kontakt:
- Elaine Brinkworth
- Telefonnummer: +4401792986806
- E-mail: Elaine.Brinkworth@wales.nhs.uk
-
-
Devon
-
Exeter, Devon, Det Forenede Kongerige, EX2 5DW
- Trukket tilbage
- Royal Devon University Healthcare NHS Trust
-
-
-
-
Alabama
-
Huntsville, Alabama, Forenede Stater, 35801
- Rekruttering
- Metro Infectious Disease Consultants
-
Kontakt:
- Aundrea Bevis
- Telefonnummer: 256-469-7200
- E-mail: abevis@innovativeventures.com
-
-
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
- Rekruttering
- GI Alliance
-
Kontakt:
- Samuel Cordivin
- Telefonnummer: 1271 623-972-2116
- E-mail: scordivin@arizonadigestivehealth.com
-
-
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:
- Debra Weinstein, MD
- Telefonnummer: 323-815-7793
- E-mail: restorative303@science37.com
-
Los Angeles, California, Forenede Stater, 90027
- Rekruttering
- Children's Hospital of Los Angeles
-
Kontakt:
- Victor Yu
- Telefonnummer: 323-361-8481
- E-mail: vyu@chla.usc.edu
-
San Diego, California, Forenede Stater, 92161
- Rekruttering
- VA San Diego Healthcare System
-
Kontakt:
- David Looney, MD
- Telefonnummer: 2585 (858) 552-8585
- E-mail: David.Looney@va.gov
-
San Dimas, California, Forenede Stater, 91773
- Trukket tilbage
- North America Research Institute
-
Thousand Oaks, California, Forenede Stater, 91360
- Rekruttering
- Clinical Trials Management Services
-
Kontakt:
- Teresa Tocher
- Telefonnummer: 805-906-7800
- E-mail: siteservices@clinicaltrialsmanagementservices.com
-
Torrance, California, Forenede Stater, 90502
- Rekruttering
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
-
Kontakt:
- Janine La Page
- Telefonnummer: 310-222-4104
- E-mail: jlapage@lundquist.org
-
-
Connecticut
-
Bristol, Connecticut, Forenede Stater, 06010
- Rekruttering
- Connecticut Clinical Research Institute
-
Kontakt:
- Cecile Guttermuth
- Telefonnummer: 860-585-3838
- E-mail: cguttermuth@connecticutgi.org
-
Hamden, Connecticut, Forenede Stater, 06518
- Rekruttering
- Medical Research Center of Connecticut
-
Kontakt:
- Candace Cotto
- Telefonnummer: 904-680-0871
- E-mail: ccotto@gastrocenter.org
-
Hartford, Connecticut, Forenede Stater, 06102
- Trukket tilbage
- Hartford Hospital
-
-
Florida
-
Clearwater, Florida, Forenede Stater, 33756
- Rekruttering
- Gastro Florida
-
Kontakt:
- Tara Wasson-Olden
- Telefonnummer: 1 727-347-0005
- E-mail: tolden@gastrofl.com
-
Kontakt:
- Shannon Brewington
- Telefonnummer: 772-336-7682
- E-mail: sbrewington@gastrofl.com
-
Fort Lauderdale, Florida, Forenede Stater, 33308
- Rekruttering
- Proactive Clinical Research, LLC
-
Kontakt:
- Carolyn Zambrano
- Telefonnummer: 954-938-2843
- E-mail: czambrano@proactivecr.com
-
Jacksonville, Florida, Forenede Stater, 32256
- Rekruttering
- Encore Borland-Groover Clinical Research
-
Kontakt:
- Cynthia Buda
- Telefonnummer: 904-621-0390
- E-mail: cbuda@encoredocs.com
-
Naples, Florida, Forenede Stater, 34102
- Rekruttering
- GI Pros Research
-
Kontakt:
- Paula Allain
- Telefonnummer: 239-649-1336
- E-mail: pallainresearch@gmail.com
-
Port Orange, Florida, Forenede Stater, 32127
- Rekruttering
- Advanced Medical Research Center
-
Kontakt:
- Mohamed Alharami
- Telefonnummer: 386-767-8800
- E-mail: mhekmat@amrcus.com
-
Saint Cloud, Florida, Forenede Stater, 34769
- Rekruttering
- KM International Research Operation LLC
-
Kontakt:
- Kadidia Kone-Merchant
- Telefonnummer: 321-805-4774
- E-mail: kad@kminternationalresearchoperationllc.com
-
Tampa, Florida, Forenede Stater, 33614
- Rekruttering
- International Center for Research
-
Kontakt:
- Laura Porro
- Telefonnummer: 786-308-1157
- E-mail: Lporro@ICR-Health.org
-
Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- James A. Haley Veterans' Hospital
-
Kontakt:
- John F Toney, MD
- Telefonnummer: 6697 813-972-2000
- E-mail: john.toney@va.gov
-
-
Georgia
-
Athens, Georgia, Forenede Stater, 30607
- Rekruttering
- Summit Clinical Research, LLC
-
Kontakt:
- Jeffrey Williams, MD
- E-mail: jwilliams@summitclinicalstudies.com
-
Atlanta, Georgia, Forenede Stater, 30308
- Rekruttering
- Emory University Hospital Midtown
-
Kontakt:
- Jennifer Truell
- Telefonnummer: 404-778-0014
- E-mail: jennifer.carter.truell@emory.edu
-
Kontakt:
- Nirja Mehta, MD
- Telefonnummer: 470-839-5804
- E-mail: nirja.mehta@emory.edu
-
Decatur, Georgia, Forenede Stater, 30033
- Rekruttering
- Metro Infectious Disease Consultants
-
Kontakt:
- Jaol Matos
- E-mail: jmatos@idsatlanta.com
-
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:
- Octavia Nichols
- Telefonnummer: 678-819-4237
- E-mail: onichols@gigeorgia.com
-
-
Idaho
-
Idaho Falls, Idaho, Forenede Stater, 83404
- Rekruttering
- Snake River Research, PLLC
-
Kontakt:
- Jennifer Morrison
- Telefonnummer: 208-535-8406
- E-mail: jmorrison@snakerr.com
-
-
Illinois
-
Burr Ridge, Illinois, Forenede Stater, 60527
- Rekruttering
- Metro Infectious Disease Consultants
-
Kontakt:
- Sarah Arnold
- Telefonnummer: 630-655-8441
- E-mail: sarnold@innovativeventures.com
-
Evanston, Illinois, Forenede Stater, 60201
- Trukket tilbage
- NorthShore University Health System - Evanston Hospital
-
Gurnee, Illinois, Forenede Stater, 60031
- Rekruttering
- GI Alliance
-
Kontakt:
- Emma Lamblin
- Telefonnummer: 224-441-2217
- E-mail: Emma.Lamblin@gialliance.com
-
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:
- Debbie Drenzyk
- Telefonnummer: 317-948-9212
- E-mail: iuibd@iupui.edu
-
Kontakt:
- Renee Hewitt
- Telefonnummer: 317-278-9294
- E-mail: iuibd@iupui.edu
-
New Albany, Indiana, Forenede Stater, 47150
- Rekruttering
- Gastroenterology Health Partners
-
Kontakt:
- Brandon Daly
- Telefonnummer: (812) 945-0145
- E-mail: Brandy.Daly@onegi.com
-
Newburgh, Indiana, Forenede Stater, 47630
- Trukket tilbage
- Deaconess GI Specialty Center
-
-
Kansas
-
Kansas City, Kansas, Forenede Stater, 66160
- Rekruttering
- University of Kansas Medical Center
-
Kontakt:
- Melissa Willer
- Telefonnummer: 913-945-6770
- E-mail: mwiller@kumc.edu
-
Kontakt:
- KUMC Research Administration
- E-mail: researchadministration@kumc.edu
-
Wichita, Kansas, Forenede Stater, 67211
- Trukket tilbage
- IDC Clinical Research, LLC
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40218
- Rekruttering
- Gastroenterology Health Partners
-
Kontakt:
- Brandon Daly
- Telefonnummer: (812) 945-0145
- E-mail: Brandy.Daly@onegi.com
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70121
- Rekruttering
- Ochsner Clinic Foundation
-
Kontakt:
- Julie Castex
- Telefonnummer: 504-842-7154
- E-mail: jcastex@ochsner.org
-
-
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:
- Gilbert Horst
- Telefonnummer: 301-652-5520
- E-mail: ghorst@jointopo.com
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Rekruttering
- Brigham and Women's Hospital
-
Kontakt:
- Grace Hardwick
- Telefonnummer: 617-525-7011
- E-mail: ghardwick@bwh.harvard.edu
-
Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Massachusetts General Hospital
-
Kontakt:
- Elizabeth Hohmann, MD
- Telefonnummer: 617-724-7432
- E-mail: ehohmann@mgh.harvard.edu
-
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:
- Kimberly Nofz
- Telefonnummer: 734-845-5522
- E-mail: kimberly.nofz@va.gov
-
Detroit, Michigan, Forenede Stater, 48202
- Rekruttering
- Henry Ford Health
-
Kontakt:
- Anita Shallal, MD
- Telefonnummer: 313-850-7032
- E-mail: ashalla2@hfhs.org
-
Royal Oak, Michigan, Forenede Stater, 48073
- Rekruttering
- Corewell Health William Beaumont University Hospital
-
Kontakt:
- Maureen Cooney
- Telefonnummer: 248-551-2544
- E-mail: Maureen.Cooney@corewellhealth.org
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55455
- Rekruttering
- University of Minnesota Medical Center
-
Kontakt:
- Makenzie Richard
- Telefonnummer: 612-625-8090
- E-mail: rich1400@umn.edu
-
Plymouth, Minnesota, Forenede Stater, 55446
- Trukket tilbage
- MNGI Digestive Health, PA
-
Rochester, Minnesota, Forenede Stater, 55905
- Rekruttering
- Mayo Clinic
-
Kontakt:
- Patricia Kramer
- Telefonnummer: 507-538-1827
- E-mail: kammer.patricia@mayo.edu
-
-
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:
- Teresa Arb
- Telefonnummer: 314-747-1217
- E-mail: arbt@wustl.edu
-
Weldon Spring, Missouri, Forenede Stater, 63304
- Rekruttering
- St. Charles Clinical Research
-
Kontakt:
- Kelly Moushey
- E-mail: k.moushey@stcharlesclinicalresearch.com
-
-
New Jersey
-
New Brunswick, New Jersey, Forenede Stater, 08901
- Rekruttering
- Rutgers Robert Wood Johnson Medical School
-
Kontakt:
- Therese Pagulayan
- Telefonnummer: 732-235-6128
- E-mail: tup1@rwjms.rutgers.edu
-
Somers Point, New Jersey, Forenede Stater, 08244
- Rekruttering
- South Jersey Infectious Disease
-
Kontakt:
- Kelly Freeman
- Telefonnummer: 5 609-927-6662
- E-mail: kelly.freeman@sjidtrials.net
-
-
New York
-
Manhasset, New York, Forenede Stater, 11030
- Rekruttering
- Northwell Health Division of Infectious Diseases
-
Kontakt:
- Jessica Rao
- Telefonnummer: 516-562-3363
- E-mail: JCabildo@Northwell.edu
-
Kontakt:
- Andrew Diaz
- E-mail: adiaz34@northwell.edu
-
New York, New York, Forenede Stater, 10016
- Rekruttering
- NYU Grossman School of Medicine
-
Kontakt:
- Nathasha Melukkaran
- Telefonnummer: 646-754-3417
- E-mail: Nathasha.melukkaran@nyulangone.org
-
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:
- Jessica Balay
- Telefonnummer: 717-914-7770
- E-mail: jbalay@gicare.com
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- Children's Hospital of Philadelphia
-
Kontakt:
- Kelly Menna
- Telefonnummer: 215-590-3669
- E-mail: mennak@chop.edu
-
Sayre, Pennsylvania, Forenede Stater, 18840
- Trukket tilbage
- Guthrie Medical Group, PC
-
Uniontown, Pennsylvania, Forenede Stater, 15401
- Rekruttering
- Frontier Clinical Research
-
Kontakt:
- Kim Chapman
- Telefonnummer: 724-596-8036
- E-mail: kchapman@frontierclinical.com
-
-
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:
- Stephanie Bhula
- Telefonnummer: 901-309-6031
- E-mail: sbhula@gastro1.com
-
Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Vanderbilt University Medical Center
-
Kontakt:
- Emily Cleveland
- Telefonnummer: 615-396-0177
- E-mail: emily.f.cleveland@vumc.org
-
-
Texas
-
Cedar Park, Texas, Forenede Stater, 78613
- Rekruttering
- GI Alliance
-
Kontakt:
- Alexa Payne
- Telefonnummer: 512-341-0900
- E-mail: Alexa.Payne@GiAlliance.com
-
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
- Rekruttering
- GI Alliance
-
Kontakt:
- Chase Mosley
- Telefonnummer: 806-793-3141
- E-mail: chase.mosley@gialliance.com
-
Sugar Land, Texas, Forenede Stater, 77478
- Trukket tilbage
- Simcare Medical Research, LLC
-
-
Virginia
-
Richmond, Virginia, Forenede Stater, 23229
- Rekruttering
- GI Alliance
-
Kontakt:
- Kristy Satkowski
- Telefonnummer: 804-362-0954
- E-mail: Kristy.Satkowski@gastrova.com
-
-
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:
- Lisa Cannon
- Telefonnummer: 414-908-6630
- E-mail: lisac@wigia.com
-
-
-
-
-
Tours, Frankrig, 37044
- Rekruttering
- Chru De Tours
-
Kontakt:
- Mohamed Dribek
- Telefonnummer: +33 2 47 47 86 22
- E-mail: m.dribek@chu-tours.fr
-
-
Auvergne-Rhône-Alpes
-
Les Paris, Auvergne-Rhône-Alpes, Frankrig, 75014
- Aktiv, ikke rekrutterende
- Hospital St. Joseph
-
-
Franche-Comté
-
Dijon, Franche-Comté, Frankrig, 21079
- Rekruttering
- Hôpital du Bocage
-
Kontakt:
- Carole Charles
- Telefonnummer: +33380295240
- E-mail: carole.charles@chu-dijon.fr
-
-
Grand Est
-
Paris, Grand Est, Frankrig, 51092 Reims Cedex
- Rekruttering
- Centre Hospitalier Universitaire (CHU) de Reims - Hopital Robert Debre
-
Kontakt:
- Giovanni Farace
- Telefonnummer: +33 (0)326784152
- E-mail: gfarace@chu-reims.fr
-
-
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:
- Jérémie Orain
- Telefonnummer: 33 02 53 48 24 25
- E-mail: jeremie.orain@chu-nantes.fr
-
-
Paris
-
Paris, Paris, Frankrig, 75018
- Rekruttering
- Assistance Publique Hôpitaux de Paris Hôpital Bichat- Claude Bernard - Département des maladies infectieuses et tropicales
-
Kontakt:
- Lynda Chalal
- Telefonnummer: 33 1 40 25 87 79
- E-mail: lynda.chalal@aphp.fr
-
-
Rhone
-
Lyon, Rhone, Frankrig, 69004
- Rekruttering
- Hôpital De La Croix Rousse - Gastroenterology
-
Kontakt:
- Emma Sandoz
- Telefonnummer: +33426732862
- E-mail: emma.sandoz@chu-lyon.fr
-
-
-
-
-
Tbilisi, Georgien, 0159
- Rekruttering
- LTD "Emergency Cardiology Center named by Acad.G.Chapidze"
-
Kontakt:
- Tinatin Kavtaradze
- Telefonnummer: +995599147799
- E-mail: Tinatinkavtaradze11@gmail.com
-
-
K'alak'i T'bilisi
-
Tbilisi, K'alak'i T'bilisi, Georgien, 0112
- Rekruttering
- ISR-GEO Med Res Clin Healthycore
-
Kontakt:
- Manana Anchabadze
- Telefonnummer: 995599777633
- E-mail: anchabadze.m@gmail.com
-
Tbilisi, K'alak'i T'bilisi, Georgien, 0160
- Rekruttering
- LTD "Academician Vakhtang Bochorishvili Clinic"
-
Kontakt:
- Sofio Iluridze
- Telefonnummer: 995574856336
- E-mail: Sofio.iluridze@yahoo.com
-
Tbilisi, K'alak'i T'bilisi, Georgien, 0160
- Rekruttering
- LTD "Aversi Clinic"
-
Kontakt:
- Maka Katsia
- Telefonnummer: +995 593343266
- E-mail: mkatsia@yahoo.com
-
-
-
-
-
Utrecht, Holland, 3584 CX
- Rekruttering
- Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
-
Kontakt:
- Iris Koevoets
- Telefonnummer: +31887567979
- E-mail: i.a.i.koevoets@umcutrecht.nl
-
-
South Holland
-
Leiden, South Holland, Holland, 2333 ZA
- Rekruttering
- Leids Universitair Medisch Centrum (LUMC)
-
Kontakt:
- Jessica Vlot
- Telefonnummer: +31715261424
- E-mail: j.a.vlot@lumc.nl
-
Kontakt:
- Joffrey van Prehn
- Telefonnummer: +310715263931
- E-mail: j.vanprehn@lumc.nl
-
-
-
-
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
-
-
-
-
-
Haifa, Israel, 31096
- Rekruttering
- Rambam Health Care Campus
-
Kontakt:
- Ilan Davidov
- Telefonnummer: +972546559224
- E-mail: il_davidov@rambam.health.gov.il
-
Kontakt:
- Anastasia Weis
- Telefonnummer: +972544518702
- E-mail: A_WEIS@rambam.health.gov.il
-
Tel HaShomer, Israel, 5265601
- Rekruttering
- The Chaim Sheba Medical Center
-
Kontakt:
- Shlomit Romano
- Telefonnummer: +97235303500
- E-mail: Shlomit.Romano@sheba.health.gov.il
-
-
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:
- Nurit Platner
- Telefonnummer: +972524266763
- E-mail: nuritp@tlvmc.gov.il
-
Tsrifin, Central District, Israel, 7030000
- Rekruttering
- Shamir Medical Center (Assaf Harofeh)
-
Kontakt:
- Hodaya Hanya
- Telefonnummer: 08-9542268
- E-mail: hodayah@shamir.gov.il
-
-
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:
- Pnina Nir
- Telefonnummer: +972-8-6745765
- E-mail: pninan@bmc.gov.il
-
-
-
-
-
Pisa, Italien, 56124
- Rekruttering
- AOU Pisana - Stabilimento di Cisanello
-
Kontakt:
- Marco Falcone, MD
- Telefonnummer: +39 050 996735
- E-mail: marco.falcone@unipi.it
-
Roma, Italien, 00186
- Rekruttering
- Ospedale Isola Tiberina Gemelli Isola
-
Kontakt:
- Caterina Fanali
- Telefonnummer: +390630155923
- E-mail: caterina.fanali@fbf-isola.it
-
-
Alessandria
-
Alessandria, Alessandria, Italien, 15121
- Rekruttering
- AO Nazionale SS. Antonio e Biagio e C. Arrigo
-
Kontakt:
- Gabriel Corbo
- Telefonnummer: +39 0131 206893
- E-mail: gabriel.corbo@aou.al.it
-
-
Lombardy
-
Lecco, Lombardy, Italien, 23900
- Rekruttering
- PO A. Manzoni di Lecco, ASST Lecco
-
Kontakt:
- Silvia Pontiggia
- Telefonnummer: +390341253678
- E-mail: s.pontiggia@asst-lecco.it
-
-
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:
- Maria Scirocco
- Telefonnummer: +393714534488
- E-mail: mmichelascirocco@hotmail.com
-
-
Pavia
-
Pavia, Pavia, Italien, 27100
- Rekruttering
- IRCCS Policlinico San Matteo, Università degli studi di Pavia
-
Kontakt:
- Mattia Demitri
- Telefonnummer: +39 0382 502523
- E-mail: m.demitri@smatteo.pv.it
-
-
Reggio Emilia
-
Modena, Reggio Emilia, Italien, 41124
- Rekruttering
- Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena - Malattie Infettive E Tropicali
-
Kontakt:
- Barbara Beghetto
- Telefonnummer: +39 0594223673
- E-mail: nb.protocolli@unimo.it
-
-
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
- Rekruttering
- Centro de Investigacion Medica Aguascalientes
-
Kontakt:
- Daniela Portillo
- Telefonnummer: +5539392977
- E-mail: daniela.portillo@osmomexico.com
-
Aguascalientes, Aguascalientes, Mexico, 20230
- Rekruttering
- Hospital Cardiologica Aguascalientes - Investigacion
-
Kontakt:
- Luz Delgado Munoz
- Telefonnummer: 315 524499154000
- E-mail: majkamaria-6@hotmail.com
-
-
Morelos
-
Cuernavaca, Morelos, Mexico, 62290
- Rekruttering
- JM Research S.C - Pediatrics
-
Kontakt:
- Rita Márquez Hernández
- Telefonnummer: 52 777 263 32 00
- E-mail: rita@jmresearch.org
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexico, 64460
- Rekruttering
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Infectious Diseases
-
Kontakt:
- Ximena Tovar Sosa
- Telefonnummer: 528671484520
- E-mail: ximenatovarso00@gmail.com
-
-
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:
- Daniela Manolache
- Telefonnummer: +40723120150
- E-mail: dani_voicu2001@yahoo.com
-
Bucharest, Bucharest, Rumænien, 030303
- Rekruttering
- Spitalul Clinic de Boli Infectioase si Tropicale Dr Victor Babes
-
Kontakt:
- Nicoleta Baloseanu
- Telefonnummer: +40763709113
- E-mail: nicoleta.baloseanu@gmail.com
-
-
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:
- Andrei Vata, MD
- Telefonnummer: +40740160580
- E-mail: andreiandrei@yahoo.com
-
-
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:
- Brais Castelo
- Telefonnummer: +34607507910
- E-mail: brais.castelo@gmail.com
-
Alicante, Spanien, 03010
- Rekruttering
- Hospital General Universitario Dr Balmis
-
Kontakt:
- Livia Giner Oncina
- Telefonnummer: +34 965 91 35 75
- E-mail: livginer@gmail.com
-
Barcelona, Spanien, 08036
- Rekruttering
- Hospital Clinic de Barcelona
-
Kontakt:
- Montserrat Solà Vidal Solà Vidal
- Telefonnummer: +34932275400
- E-mail: msola@recerca.clinic.cat
-
Barcelona, Spanien, 08041
- Rekruttering
- Hospital de La Santa Creu i Sant Pau
-
Kontakt:
- Iris Artesero Sosa
- Telefonnummer: +34625916595
- E-mail: IArtesero@santpau.cat
-
Córdoba, Spanien, 14004
- Rekruttering
- Hospital Universitario Reina Sofia
-
Kontakt:
- Patricia Cosano Perez
- Telefonnummer: +34633339548
- E-mail: patricia.cosano@imibic.org
-
Madrid, Spanien, 28034
- Rekruttering
- Hospital Universitario Ramón y Cajal
-
Kontakt:
- Celia Cano Sanz
- Telefonnummer: +34913369071
- E-mail: celiacanosz.ec@gmail.com
-
Seville, Spanien, 41009
- Rekruttering
- Hospital Universitario Virgen De La Macarena
-
Kontakt:
- Virginia Palomo Jimenez Palomo Jimenez
- Telefonnummer: +34955926553
- E-mail: virgi2015@hotmail.com
-
-
Barcelona
-
Badalona, Barcelona, Spanien, 08916
- Rekruttering
- Hospital Universitari Germans Trias i Pujol
-
Kontakt:
- Elena Abad
- Telefonnummer: +34 93 497 83 49
- E-mail: eabad@scienhub.org
-
Barcelona, Barcelona, Spanien, 08907
- Rekruttering
- Hospital Universitario de Bellvitge
-
Kontakt:
- Judit Orobitg Bernandes
- Telefonnummer: 34 93 260 75 00
- E-mail: orobitg@bellvitgehospital.cat
-
Terrassa, Barcelona, Spanien, 08221
- Aktiv, ikke rekrutterende
- Hospital Universitario Mutua de Terrassa
-
-
Guipúzcoa
-
San Sebastián, Guipúzcoa, Spanien, 20014
- Rekruttering
- H. U. Donostia
-
Kontakt:
- Claudia Nevado Pavón
- Telefonnummer: +34 943003535
- E-mail: claudia.nevadopavon@bio-gipuzkoa.eus
-
-
Madrid
-
Madrid, Madrid, Spanien, 28007
- Rekruttering
- Gregorio Marañón University Hospital
-
Kontakt:
- Sara Rodriguez
- Telefonnummer: +34915865492
- E-mail: sara.rodriguezinvestigacion@hotmail.com
-
Madrid, Madrid, Spanien, 28046
- Rekruttering
- Hospital Universitario La Paz - UCICEC
-
Kontakt:
- Ana Maria Ortega
- Telefonnummer: +34912071876
- E-mail: ana.ucicec@gmail.com
-
Majadahonda, Madrid, Spanien, 28222
- Rekruttering
- Hospital Universitario Puerta De Hierro Majadahonda
-
Kontakt:
- Paloma Rodríguez Araque
- Telefonnummer: +34911916481
- E-mail: farmacologia_clinica@idiphim.org
-
-
Sevilla
-
Seville, Sevilla, Spanien, 41014
- Rekruttering
- Hospital Universitario Virgen Macarena
-
Kontakt:
- María del Rocio Herrero del Río
- Telefonnummer: +34955015871
- E-mail: rocio.herrero.delrio@gmail.com
-
-
-
-
Gangwon-do
-
Wŏnju, Gangwon-do, Sydkorea, 26426
- Aktiv, ikke rekrutterende
- Yonsei University, Wonju Severance Christian Hospital
-
-
Seoul Teugbyeolsi
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
Kontakt:
- Ji Eun Kim
- Telefonnummer: 82234103409
- E-mail: happyjinny0706@gmail.com
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 07441
- Rekruttering
- Hallym University Kangnam Sacred Heart Hospital
-
Kontakt:
- Bokyung Yun
- Telefonnummer: +10-6728-7172
- E-mail: ybk0618@naver.com
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 06591
- Rekruttering
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Kontakt:
- Yun Jeong
- Telefonnummer: 82 2 2258 2084
- E-mail: yjchoi1689@gmail.com
-
-
-
-
Kaohsiung
-
Kaohsiung City, Kaohsiung, Taiwan, 80756
- Rekruttering
- KMU Chung-Ho Memorial Hospital
-
Kontakt:
- Yan-Zhen Hsu
- Telefonnummer: +886 963383335
- E-mail: hannah.hsu530@gmail.com
-
-
Taichung
-
Taichung, Taichung, Taiwan, 404327
- Rekruttering
- China Medical University Hospital - Infectious
-
Kontakt:
- Ya Chun Tang
- Telefonnummer: +886 975297510
- E-mail: yachun620@gmail.com
-
-
Taoyuan
-
Taoyuan, Taoyuan, Taiwan, 333423
- Rekruttering
- Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
-
Kontakt:
- Wen-Leng Chou
- Telefonnummer: 8848 88633281200
- E-mail: a5896067@yahoo.com.tw
-
-
-
-
-
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
-
Frankfurt am Main, Hesse, Tyskland, 60590
- Rekruttering
- University Hospital Frankfurt
-
Kontakt:
- Guido Neumann
- Telefonnummer: +49 69 630185236
- E-mail: Guido.Neumann@unimedizin-ffm.de
-
Kontakt:
- Ester Mostazo-Mendoza
- Telefonnummer: +49 69 86540
- E-mail: ester.mostazomendoza@unimedizin-ffm.de
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-
North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, Tyskland, 50937
- Rekruttering
- University Hospital Cologne AöR - Klinik I für Innere Medizin
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Kontakt:
- Tatjana Lammertz
- Telefonnummer: +4922147897340
- E-mail: tatjana.lammertz@uk-koeln.de
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-
State of Berlin
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Berlin, State of Berlin, Tyskland, 12157
- Rekruttering
- Epimed GmbH
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Kontakt:
- Juliane Grube
- Telefonnummer: +49 30 26558370
- E-mail: grube@epimed.org
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-
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-
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Budapest, Ungarn, 1088
- Aktiv, ikke rekrutterende
- Semmelweis Egyetem
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Nyíregyháza, Ungarn, 4400
- Trukket tilbage
- Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház Nyíregyházi Jósa András Tagkórház
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-
Bekes County
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Békéscsaba, Bekes County, Ungarn, 5600
- Trukket tilbage
- Bekes Varmegyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
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Csongrád megye
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Szeged, Csongrád megye, Ungarn, H-6725
- Trukket tilbage
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. sz. Belgyogyaszati Klinika
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Komárom-Esztergom
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Tatabánya, Komárom-Esztergom, Ungarn, 2800
- Aktiv, ikke rekrutterende
- Komárom-Esztergom Vármegyei Szent Borbála Kórház
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-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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:
- Age ≥ 65 years
- Kidney dysfunction, defined as estimated creatinine clearance < 60 mL/min/1.73 m^2 at the time of the qualifying CDI episode
- 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
- History of a prior CDI episode between 6 and 12 months prior to enrollment
- Immunosuppression due to an underlying disease or its treatment
- 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:
- New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days
- CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI
- 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
- Diarrhea considered unlikely to have another etiology
-
Prior to receiving any study medication, the participant should:
- 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.
- 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
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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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / 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
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
Sponsor
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
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
Studerer et amerikansk FDA-reguleret enhedsprodukt
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