VE303 for Prevention of Recurrent Clostridioides Difficile Infection

NCT ID: NCT06237452

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

852 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2027-10-31

Brief Summary

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The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).

Detailed Description

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Conditions

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Clostridium Difficile Clostridium Difficile Infections Clostridium Difficile Infection Recurrence Clostridioides Difficile Infection Clostridioides Difficile Infection Recurrence CDI C. Diff Infection Recurrent Clostridium Difficile Infection C.Difficile Diarrhea Diarrhea Infectious

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

VE303

Intervention Type BIOLOGICAL

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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.

Interventions

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VE303

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

Intervention Type BIOLOGICAL

Placebo

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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


* 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


* 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

Exclusion Criteria

* 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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vedanta Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Advanced Gastroenterology, P.C.

Chandler, Arizona, United States

Site Status WITHDRAWN

Mayo Clinic Hospital

Phoenix, Arizona, United States

Site Status WITHDRAWN

Om Research, LLC

Apple Valley, California, United States

Site Status RECRUITING

Science 37 Inc (Remote/Home option)

Culver City, California, United States

Site Status RECRUITING

VA San Diego Healthcare System

San Diego, California, United States

Site Status RECRUITING

North America Research Institute

San Dimas, California, United States

Site Status RECRUITING

Clinical Trials Management Services

Thousand Oaks, California, United States

Site Status RECRUITING

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

Site Status RECRUITING

Medical Research Center of Connecticut

Hamden, Connecticut, United States

Site Status RECRUITING

Hartford Hospital

Hartford, Connecticut, United States

Site Status WITHDRAWN

Gastro Florida

Clearwater, Florida, United States

Site Status RECRUITING

Proactive Clinical Research, LLC

Fort Lauderdale, Florida, United States

Site Status RECRUITING

Encore Borland-Groover Clinical Research

Jacksonville, Florida, United States

Site Status RECRUITING

GI Pros Research

Naples, Florida, United States

Site Status RECRUITING

Advanced Medical Research Center

Port Orange, Florida, United States

Site Status RECRUITING

KM International Research Operation LLC

Saint Cloud, Florida, United States

Site Status RECRUITING

James A. Haley Veterans' Hospital

Tampa, Florida, United States

Site Status RECRUITING

International Center for Research

Tampa, Florida, United States

Site Status RECRUITING

Summit Clinical Research, LLC

Athens, Georgia, United States

Site Status RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status RECRUITING

Metro Infectious Disease Consultants

Decatur, Georgia, United States

Site Status RECRUITING

Regional Infectious Diseases and Infusion Center, Inc.

La Grange, Georgia, United States

Site Status RECRUITING

Gastrointestinal Specialists of Georgia

Marietta, Georgia, United States

Site Status RECRUITING

Snake River Research, PLLC

Idaho Falls, Idaho, United States

Site Status RECRUITING

Metro Infectious Disease Consultants

Burr Ridge, Illinois, United States

Site Status RECRUITING

NorthShore University Health System - Evanston Hospital

Evanston, Illinois, United States

Site Status RECRUITING

Innovative Clinical Research Center, LLC (ICRC)

Island Lake, Illinois, United States

Site Status RECRUITING

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Site Status RECRUITING

Deaconess GI Specialty Center

Newburgh, Indiana, United States

Site Status RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

IDC Clinical Research, LLC

Wichita, Kansas, United States

Site Status WITHDRAWN

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

MGG Group Co., Inc., Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Site Status RECRUITING

Tufts Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

LTC Charles S. Kettles VA Medical Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

Henry Ford Health

Detroit, Michigan, United States

Site Status RECRUITING

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Site Status RECRUITING

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

MNGI Digestive Health, PA

Plymouth, Minnesota, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Delta Gastroenterology and Endoscopy Center

Southaven, Mississippi, United States

Site Status RECRUITING

University of Missouri

Columbia, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

St. Charles Clinical Research

Weldon Spring, Missouri, United States

Site Status RECRUITING

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status RECRUITING

South Jersey Infectious Disease

Somers Point, New Jersey, United States

Site Status RECRUITING

Northwell Health Division of Infectious Diseases

Manhasset, New York, United States

Site Status RECRUITING

NYU Grossman School of Medicine

New York, New York, United States

Site Status RECRUITING

New York Presbyterian Hospital

New York, New York, United States

Site Status RECRUITING

Manhattan Clinical Research, LLC

New York, New York, United States

Site Status RECRUITING

Syracuse VA Medical Center

Syracuse, New York, United States

Site Status RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Toledo Institute of Clinical Research

Toledo, Ohio, United States

Site Status RECRUITING

Oklahoma City Veterans Affairs Healthcare System

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Susquehanna Research Group - Gastroenterology

Harrisburg, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Guthrie Medical Group, PC

Sayre, Pennsylvania, United States

Site Status RECRUITING

Frontier Clinical Research

Uniontown, Pennsylvania, United States

Site Status RECRUITING

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, United States

Site Status RECRUITING

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, United States

Site Status RECRUITING

Lowcountry Infectious Diseases, P.A.

Charleston, South Carolina, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

North Texas Infectious Disease Consultants, P.A.

Dallas, Texas, United States

Site Status RECRUITING

University of Houston College of Pharmacy

Houston, Texas, United States

Site Status WITHDRAWN

BioStar Clinical Research

Katy, Texas, United States

Site Status WITHDRAWN

Simcare Medical Research, LLC

Sugar Land, Texas, United States

Site Status RECRUITING

Seattle Infectious Disease Clinic

Seattle, Washington, United States

Site Status WITHDRAWN

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Site Status RECRUITING

Westmead Hospital

Westmead, New South Wales, Australia

Site Status RECRUITING

Monash Health

Clayton, Victoria, Australia

Site Status RECRUITING

Melbourne Health

Parkville, Victoria, Australia

Site Status RECRUITING

Erasme University Hospital - Infectiology Department

Anderlecht, , Belgium

Site Status RECRUITING

Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status RECRUITING

CCIH - Consultoria em Controle de Infecção Hospitalar Ltda

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Hospital Nossa Senhora das Graças

Curitiba, Paraná, Brazil

Site Status RECRUITING

CPCLIN - Centro de Estudos e Pesquisas em Molestias Infecciosas - Pesquisa Clínica

Natal, Rio Grande do Norte, Brazil

Site Status RECRUITING

Fundacao Universidade de Caxias do Sul - Hospital Geral de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital de Clinicas de Porto Alegre - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Medical Center Excelsior OOD, Base 1

Sofia, Sofia-Grad, Bulgaria

Site Status RECRUITING

UMHAT Burgas AD

Burgas, , Bulgaria

Site Status RECRUITING

Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD

Gorna Oryahovitsa, , Bulgaria

Site Status RECRUITING

Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOOD

Lom, , Bulgaria

Site Status RECRUITING

Medicinski centar Hipokrat-N EOOD

Plovdiv, , Bulgaria

Site Status RECRUITING

MHAT Dr.Ivan Seliminski - Sliven Ltd.

Sliven, , Bulgaria

Site Status RECRUITING

Alberta Health Services (AHS) - Foothills Medical Centre

Calgary, Alberta, Canada

Site Status RECRUITING

University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

CaRe Clinic

Red Deer, Alberta, Canada

Site Status RECRUITING

Vancouver Coastal Health Research Institute Clinical Research Unit

Vancouver, British Columbia, Canada

Site Status RECRUITING

The Moncton Hospital

Moncton, New Brunswick, Canada

Site Status RECRUITING

NL Health Services

St. John's, Newfoundland and Labrador, Canada

Site Status RECRUITING

Research St. Josephs Hamilton

Hamilton, Ontario, Canada

Site Status RECRUITING

St. Joseph's Hospital - London

London, Ontario, Canada

Site Status RECRUITING

Viable Clinical Research Corporation

Scarborough Village, Ontario, Canada

Site Status WITHDRAWN

University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

INTERMED groupe santé

Chicoutimi, Quebec, Canada

Site Status RECRUITING

Centre Hospitalier de l Universite Laval (CHUL)

Québec, Quebec, Canada

Site Status RECRUITING

Fakultni nemocnice Brno

Brno, Brno-město, Czechia

Site Status RECRUITING

Nemocnice Kyjov, p.o.

Kyjov, , Czechia

Site Status WITHDRAWN

Fakultni Nemocnice Ostrava

Ostrava-Poruba, , Czechia

Site Status RECRUITING

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Site Status RECRUITING

Hospital St. Joseph

Les Paris, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Hôpital du Bocage

Dijon, Franche-Comté, France

Site Status RECRUITING

Centre Hospitalier Universitaire (CHU) de Reims - Hopital Robert Debre

Paris, Grand Est, France

Site Status RECRUITING

CHU Bordeaux - Hopital Saint Andre Service de medecine interne et maladies infectieuses

Bordeaux Cedex, Hauts-de-France, France

Site Status RECRUITING

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Ile-de-France Ouest - Raymond-Poincare

Garches, Hauts-de-Seine, France

Site Status RECRUITING

CHU de Nantes - Hôtel Dieu

Nantes, Loire-Atlantique, France

Site Status RECRUITING

Assistance Publique Hôpitaux de Paris Hôpital Bichat- Claude Bernard - Département des maladies infectieuses et tropicales

Paris, Paris, France

Site Status RECRUITING

Hôpital De La Croix Rousse - Gastroenterology

Lyon, Rhone, France

Site Status RECRUITING

Chru De Tours

Tours, , France

Site Status RECRUITING

ISR-GEO Med Res Clin Healthycore

Tbilisi, K'alak'i T'bilisi, Georgia

Site Status RECRUITING

LTD "Academician Vakhtang Bochorishvili Clinic"

Tbilisi, K'alak'i T'bilisi, Georgia

Site Status RECRUITING

LTD "Aversi Clinic"

Tbilisi, K'alak'i T'bilisi, Georgia

Site Status RECRUITING

LTD "Emergency Cardiology Center named by Acad.G.Chapidze"

Tbilisi, , Georgia

Site Status RECRUITING

University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

University Hospital Cologne AöR - Klinik I für Innere Medizin

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Epimed GmbH

Berlin, State of Berlin, Germany

Site Status RECRUITING

Bekes Varmegyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

Békéscsaba, Bekes County, Hungary

Site Status RECRUITING

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. sz. Belgyogyaszati Klinika

Szeged, Csongrád megye, Hungary

Site Status RECRUITING

Komárom-Esztergom Vármegyei Szent Borbála Kórház

Tatabánya, Komárom-Esztergom, Hungary

Site Status RECRUITING

Semmelweis Egyetem

Budapest, , Hungary

Site Status RECRUITING

Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház Nyíregyházi Jósa András Tagkórház

Nyíregyháza, , Hungary

Site Status RECRUITING

Royal College of Surgeons in Ireland - Beaumont Hospital - Education and Research Centre

Dublin, Dublin, Ireland

Site Status RECRUITING

Our Lady of Lourdes Hospital

Drogheda, Louth, Ireland

Site Status RECRUITING

Rabin Medical Center - Beilinson Hospital

Petah Tikva, Central District, Israel

Site Status RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, Central District, Israel

Site Status RECRUITING

Shamir Medical Center (Assaf Harofeh)

Ẕerifin, Central District, Israel

Site Status RECRUITING

Carmel Medical Center

Haifa, Haifa District, Israel

Site Status RECRUITING

Hillel Yaffe MC, Clinical Research Unit

Hadera, Haifa North, Israel

Site Status RECRUITING

Hadassah Medical Centre

Jerusalem, Jerusalem, Israel

Site Status RECRUITING

The Barzilai Medical Center

Ashkelon, Southern District, Israel

Site Status RECRUITING

Rambam Health Care Campus

Haifa, , Israel

Site Status RECRUITING

The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status RECRUITING

AO Nazionale SS. Antonio e Biagio e C. Arrigo

Alessandria, Alessandria, Italy

Site Status RECRUITING

PO A. Manzoni di Lecco, ASST Lecco

Lecco, Lombardy, Italy

Site Status RECRUITING

Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco

Milan, Milano, Italy

Site Status RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Federico II

Napoli, Napoli, Italy

Site Status RECRUITING

IRCCS Policlinico San Matteo, Università degli studi di Pavia

Pavia, Pavia, Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena - Malattie Infettive E Tropicali

Modena, Reggio Emilia, Italy

Site Status RECRUITING

Osp. Pediatrico Bambino Gesù, IRCCS

Roma, Roma, Italy

Site Status RECRUITING

Presidio Ospedaliero di Vittorio Veneto

Vittorio Veneto, Veneto, Italy

Site Status RECRUITING

AOU Pisana - Stabilimento di Cisanello

Pisa, , Italy

Site Status RECRUITING

Ospedale Isola Tiberina Gemelli Isola

Roma, , Italy

Site Status RECRUITING

Centro de Investigacion Medica Aguascalientes

Aguascalientes, Aguascalientes, Mexico

Site Status RECRUITING

Hospital Cardiologica Aguascalientes - Investigacion

Aguascalientes, Aguascalientes, Mexico

Site Status RECRUITING

Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Infectious Diseases

Monterrey, Nuevo León, Mexico

Site Status RECRUITING

FAICIC S de RL de C.V. - Gastroenterology

Veracruz, Veracruz, Mexico

Site Status RECRUITING

Leids Universitair Medisch Centrum (LUMC)

Leiden, South Holland, Netherlands

Site Status RECRUITING

Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care

Utrecht, , Netherlands

Site Status RECRUITING

NZOZ VIVAMED Jadwiga Miecz

Warsaw, Masovian Voivodeship, Poland

Site Status WITHDRAWN

Gyncentrum sp. z o.o.

Katowice, Silesian Voivodeship, Poland

Site Status RECRUITING

Unidade Local De Saude Do Alto Ave E.P.E.

Guimarães, Braga District, Portugal

Site Status RECRUITING

Unidade Local De Saude De Coimbra E.P.E.

Coimbra, Coimbra District, Portugal

Site Status RECRUITING

Unidade Local De Saude De Almada-Seixal E.P.E.

Almada, Lisbon District, Portugal

Site Status RECRUITING

CCAB Centro Clinico Academico Braga Associacao - ULS Braga

Braga, , Portugal

Site Status RECRUITING

Unidade Local de Saúde da Guarda (ULSG)

Guarda, , Portugal

Site Status RECRUITING

Unidade Local De Saude De Santo Antonio E.P.E.

Porto, , Portugal

Site Status RECRUITING

Unidade Local De Saude De Gaia/Espinho E.P.E.

Vila Nova de Gaia, , Portugal

Site Status RECRUITING

Institutul de Boli Infecțioase Prof Dr Matei Bals - Infectious diseases V

Bucharest, București, Romania

Site Status RECRUITING

Spitalul Clinic de Boli Infectioase si Tropicale Dr Victor Babes

Bucharest, București, Romania

Site Status RECRUITING

Spitalul Clinic de Boli Infectioase Cluj-Napoca

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Centrul Medical Renasterea

Craiova, Dolj, Romania

Site Status RECRUITING

Spitalul Clinic de Boli Infectioase Sfanta Parascheva Iasi - Infectious diseases I

Iași, Iaşi, Romania

Site Status RECRUITING

Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara

Timișoara, Timiș County, Romania

Site Status RECRUITING

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status RECRUITING

Hospital Universitario de Bellvitge

Barcelona, Barcelona, Spain

Site Status RECRUITING

Hospital Universitario Mutua de Terrassa

Terrassa, Barcelona, Spain

Site Status RECRUITING

H. U. Donostia

San Sebastián, Guipúzcoa, Spain

Site Status RECRUITING

Gregorio Marañón University Hospital

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital Universitario La Paz - UCICEC

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital Universitario Puerta De Hierro Majadahonda

Majadahonda, Madrid, Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Site Status RECRUITING

Complexo Hospitalario Universitario A Coruña

A Coruña, , Spain

Site Status RECRUITING

Hospital General Universitario Dr Balmis

Alicante, , Spain

Site Status RECRUITING

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital de La Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Reina Sofia

Córdoba, , Spain

Site Status RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen De La Macarena

Seville, , Spain

Site Status RECRUITING

KMU Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, Taiwan

Site Status RECRUITING

China Medical University Hospital - Infectious

Taichung, Taichung, Taiwan

Site Status RECRUITING

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, Taiwan

Site Status RECRUITING

Royal Devon University Healthcare NHS Trust

Exeter, Devon, United Kingdom

Site Status WITHDRAWN

The Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Site Status WITHDRAWN

North Bristol NHS Trust - Southmead Hospital, Clinical Research Centre

Bristol, , United Kingdom

Site Status RECRUITING

NHS Lothian - Western General Hospital

Edinburgh, , United Kingdom

Site Status RECRUITING

Royal Free London NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

St.Thomas' Hospital

London, , United Kingdom

Site Status RECRUITING

Northern General Hospital

Sheffield, , United Kingdom

Site Status RECRUITING

Morriston Hospital

Swansea, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Belgium Brazil Bulgaria Canada Czechia Denmark France Georgia Germany Hungary Ireland Israel Italy Mexico Netherlands Poland Portugal Romania South Korea Spain Taiwan United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mary Garfield

Role: CONTACT

Phone: 857-706-1427

Email: [email protected]

Steven Shiff, MD

Role: CONTACT

Phone: 857-706-1427

Email: [email protected]

Facility Contacts

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Tara Mckenzie

Role: primary

Debra Weinstein, MD

Role: primary

David Looney, MD

Role: primary

Yesenia Olivas

Role: primary

Syeda Naqvi

Role: backup

Teresa Tocher

Role: primary

Janine La Page

Role: primary

Candace Cotto

Role: primary

Tara Wasson-Olden

Role: primary

Shannon Brewington

Role: backup

Carolyn Zambrano

Role: primary

Cynthia Buda

Role: primary

Paula Allain

Role: primary

Mohamed Alharami

Role: primary

Kadidia Kone-Merchant

Role: primary

John F Toney, MD

Role: primary

Laura Porro

Role: primary

Jeffrey Williams, MD

Role: primary

Nirja Mehta, MD

Role: primary

Jennifer Truell

Role: backup

Jaol Matos

Role: primary

Bhuvan Doneepudi

Role: primary

Octavia Nichols

Role: primary

Jennifer Morrison

Role: primary

Sarah Arnold

Role: primary

Kirsten Anderson

Role: primary

Bibi Ugbi-Okonkwo

Role: primary

Renee Hewitt

Role: primary

Debbie Drenzyk

Role: backup

Madeline Bryant

Role: primary

Melissa Willer

Role: primary

KUMC Research Administration

Role: backup

Julie Castex

Role: primary

Zoey Onambele

Role: primary

Sean Anderson

Role: backup

Gilbert Horst

Role: primary

Dulia Santos

Role: primary

Elizabeth Hohmann, MD

Role: primary

Grace Hardwick

Role: primary

Kimberly Nofz

Role: primary

Anita Shallal, MD

Role: primary

Maureen Cooney

Role: primary

Makenzie Richard

Role: primary

Gloriah Omwanda

Role: primary

Patricia Kramer

Role: primary

Cassandra Smith

Role: primary

Syed Naqvi, MD

Role: primary

Teresa Arb

Role: primary

Kelly Moushey

Role: primary

Therese Pagulayan

Role: primary

Kelly Freeman

Role: primary

Jessica Rao

Role: primary

Andrew Diaz

Role: backup

Nathasha Melukkaran

Role: primary

Tiffany Min

Role: primary

Glenda Alfonso-Castillo

Role: primary

Maryanne Roberts

Role: primary

Faheem Husain

Role: primary

Stephen Farriester

Role: primary

George Kurdgelashvili, MD

Role: backup

Jessica Balay

Role: primary

Kelly Menna

Role: primary

Ukorn Srivatana, MD

Role: primary

Kim Chapman

Role: primary

Elina Bolukbasi

Role: primary

Susan Caulder

Role: primary

Christine Horne

Role: primary

Alicia Hartley

Role: primary

Emily Cleveland

Role: primary

Jessica Caldwell

Role: primary

Armgan Khan

Role: primary

Emily Chesterfield

Role: primary

Melissa Kermeen

Role: primary

Neela Joshi

Role: primary

Nanw Gwenallt

Role: primary

Joanne Patterson

Role: primary

Odette Mukangenzi

Role: primary

Celine D'Aoust

Role: primary

Els Caluwe

Role: primary

Daniela Mendes

Role: primary

Otavio Henrique Tomczak Paulichei

Role: primary

Sibele Araujo

Role: primary

Ramone Bertussi

Role: primary

Taiane Vieira

Role: primary

Gabriela Crestani

Role: primary

Daniela Maia

Role: primary

Ivan Lyutakov

Role: primary

Velina Pramatarova

Role: primary

Alexander Gospodinov

Role: primary

Stela Georgieva

Role: primary

Doychin Delchev

Role: primary

Silvia Mihaylova

Role: primary

Thomas Louie, MD

Role: primary

Rose Franz

Role: primary

Kayla Tiessen

Role: primary

Ariel Huang

Role: primary

Chantal Houser

Role: primary

Marie Josephine Faye

Role: primary

Adam Weerdenburg

Role: primary

Mahnaz Kazi

Role: primary

Maria Kulikova

Role: primary

Nancy Lavoie

Role: primary

Isabelle Chabot

Role: primary

Roman Stebel, MD

Role: primary

Marcela Benkova

Role: primary

Toto Nairn

Role: primary

Sabrina Bousta

Role: primary

Carole Charles

Role: primary

Giovanni Farace

Role: primary

Jean Delaune

Role: primary

Clara Duran

Role: primary

Jérémie Orain

Role: primary

Lynda Chalal

Role: primary

Emma Sandoz

Role: primary

Mohamed Dribek

Role: primary

Manana Anchabadze

Role: primary

Sofio Iluridze

Role: primary

Maka Katsia

Role: primary

Tinatin Kavtaradze

Role: primary

Ester Mostazo-Mendoza

Role: primary

Guido Neumann

Role: backup

Tatjana Lammertz

Role: primary

Juliane Grube

Role: primary

Andrea Opra

Role: primary

Patrik Szatmari

Role: primary

Adrienn Heisz

Role: primary

Kinga Kover

Role: primary

Edit Simon

Role: primary

Claire Foley

Role: primary

Adrienne Benford

Role: primary

Maayan Huber-Karl

Role: primary

Vered Daitch

Role: backup

Nurit Platner

Role: primary

Hodaya Hanya

Role: primary

Moran Rad

Role: primary

Jenny Elber

Role: primary

Lucy Merhasin

Role: backup

Jacob Strahilevitz, MD

Role: primary

Pnina Nir

Role: primary

Ilan Davidov

Role: primary

Anastasia Weis

Role: backup

Shlomit Romano

Role: primary

Gabriel Corbo

Role: primary

Silvia Pontiggia

Role: primary

Olimpia Padula

Role: primary

Anna Spolti

Role: primary

Maria Scirocco

Role: primary

Mattia Demitri

Role: primary

Barbara Beghetto

Role: primary

Giorgia Copponi

Role: primary

Adriano Mazzer

Role: primary

Marco Falcone, MD

Role: primary

Caterina Fanali

Role: primary

Daniela Portillo

Role: primary

Luz Delgado Munoz

Role: primary

Ximena Tovar Sosa

Role: primary

Astrid Hernandez Gongora

Role: primary

Jessica Vlot

Role: primary

Joffrey van Prehn

Role: backup

Iris Koevoets

Role: primary

Tomasz Rudka

Role: primary

Karolina Leopold

Role: backup

Beatriz Navio

Role: primary

Jose Pedro

Role: primary

Francisco Vale, MD

Role: primary

Joana Santos

Role: primary

Ana Xavier

Role: primary

Micaela Pintor

Role: primary

Carla Branca

Role: primary

Daniela Manolache

Role: primary

Nicoleta Baloseanu

Role: primary

Astrid Binder

Role: primary

Adina Kamal

Role: primary

Andrei Vata, MD

Role: primary

Dorian Dragulescu

Role: primary

Myung Sook

Role: primary

Ji Eun Kim

Role: primary

Bokyung Yun

Role: primary

Elena Abad

Role: primary

Judit Orobitg Bernandes

Role: primary

Cristina Badia Marti

Role: primary

Claudia Nevado Pavón

Role: primary

Sara Rodriguez

Role: primary

Ana Maria Ortega

Role: primary

Paloma Rodríguez Araque

Role: primary

María del Rocio Herrero del Río

Role: primary

Brais Castelo

Role: primary

Livia Giner Oncina

Role: primary

Montserrat Solà Vidal Solà Vidal

Role: primary

Iris Artesero Sosa

Role: primary

Patricia Cosano Perez

Role: primary

Celia Cano Sanz

Role: primary

Virginia Palomo Jimenez Palomo Jimenez

Role: primary

Yan-Zhen Hsu

Role: primary

Ya Chun Tang

Role: primary

Wen-Leng Chou

Role: primary

Kirstie Bradburn

Role: primary

Amy Shepherd

Role: primary

Audrey Abdul

Role: primary

Alieza Rara

Role: primary

Priya Lata

Role: primary

Elaine Brinkworth

Role: primary

Related Links

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Other Identifiers

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VE303-003

Identifier Type: -

Identifier Source: org_study_id