A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Status: Recruiting
Location: See all (189) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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:

‣ 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

• 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

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

Locations
United States
Arizona
Advanced Gastroenterology, P.C.
RECRUITING
Chandler
California
Om Research, LLC
RECRUITING
Apple Valley
Science 37 Inc (Remote/Home option)
RECRUITING
Culver City
VA San Diego Healthcare System
RECRUITING
San Diego
North America Research Institute
RECRUITING
San Dimas
Clinical Trials Management Services
RECRUITING
Thousand Oaks
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
RECRUITING
Torrance
Connecticut
Medical Research Center of Connecticut
RECRUITING
Hamden
Florida
Gastro Florida
RECRUITING
Clearwater
Proactive Clinical Research, LLC
RECRUITING
Fort Lauderdale
Encore Borland-Groover Clinical Research
RECRUITING
Jacksonville
GI Pros Research
RECRUITING
Naples
Advanced Medical Research Center
RECRUITING
Port Orange
KM International Research Operation LLC
RECRUITING
Saint Cloud
International Center for Research
RECRUITING
Tampa
James A. Haley Veterans' Hospital
RECRUITING
Tampa
Georgia
Summit Clinical Research, LLC
RECRUITING
Athens
Emory University Hospital Midtown
RECRUITING
Atlanta
Metro Infectious Disease Consultants
RECRUITING
Decatur
Regional Infectious Diseases and Infusion Center, Inc.
RECRUITING
La Grange
Gastrointestinal Specialists of Georgia
RECRUITING
Marietta
Idaho
Snake River Research, PLLC
RECRUITING
Idaho Falls
Illinois
Metro Infectious Disease Consultants
RECRUITING
Burr Ridge
NorthShore University Health System - Evanston Hospital
RECRUITING
Evanston
Innovative Clinical Research Center, LLC (ICRC)
RECRUITING
Island Lake
Indiana
Indiana University Health University Hospital
RECRUITING
Indianapolis
Deaconess GI Specialty Center
RECRUITING
Newburgh
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
IDC Clinical Research, LLC
RECRUITING
Wichita
Louisiana
Ochsner Clinic Foundation
RECRUITING
New Orleans
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
MGG Group Co., Inc., Chevy Chase Clinical Research
RECRUITING
Chevy Chase
Michigan
LTC Charles S. Kettles VA Medical Center
RECRUITING
Ann Arbor
Henry Ford Health
RECRUITING
Detroit
Corewell Health William Beaumont University Hospital
RECRUITING
Royal Oak
Minnesota
University of Minnesota Medical Center
RECRUITING
Minneapolis
MNGI Digestive Health, PA
RECRUITING
Plymouth
Mayo Clinic
RECRUITING
Rochester
Missouri
University of Missouri
RECRUITING
Columbia
Washington University School of Medicine
RECRUITING
St Louis
St. Charles Clinical Research
RECRUITING
Weldon Spring
Mississippi
Delta Gastroenterology and Endoscopy Center
RECRUITING
Southaven
New Jersey
Rutgers Robert Wood Johnson Medical School
RECRUITING
New Brunswick
South Jersey Infectious Disease
RECRUITING
Somers Point
New York
Northwell Health Division of Infectious Diseases
RECRUITING
Manhasset
Manhattan Clinical Research, LLC
RECRUITING
New York
New York Presbyterian Hospital
RECRUITING
New York
NYU Grossman School of Medicine
RECRUITING
New York
Syracuse VA Medical Center
RECRUITING
Syracuse
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Toledo Institute of Clinical Research
RECRUITING
Toledo
Oklahoma
Oklahoma City Veterans Affairs Healthcare System
RECRUITING
Oklahoma City
Pennsylvania
Susquehanna Research Group - Gastroenterology
RECRUITING
Harrisburg
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Guthrie Medical Group, PC
RECRUITING
Sayre
Frontier Clinical Research
RECRUITING
Uniontown
South Carolina
Lowcountry Infectious Diseases, P.A.
RECRUITING
Charleston
Medical University of South Carolina
RECRUITING
Charleston
Ralph H. Johnson VA Health Care System
RECRUITING
Charleston
Ralph H. Johnson VA Health Care System
RECRUITING
Charleston
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
North Texas Infectious Disease Consultants, P.A.
RECRUITING
Dallas
BioStar Clinical Research
RECRUITING
Katy
Simcare Medical Research, LLC
RECRUITING
Sugar Land
Washington
Seattle Infectious Disease Clinic
RECRUITING
Seattle
Virginia Mason Medical Center
RECRUITING
Seattle
Other Locations
Australia
Monash Health
RECRUITING
Clayton
Concord Repatriation General Hospital
RECRUITING
Concord
Melbourne Health
RECRUITING
Parkville
Westmead Hospital
RECRUITING
Westmead
Belgium
Erasme University Hospital - Infectiology Department
RECRUITING
Anderlecht
Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
Universitair Ziekenhuis Gent
RECRUITING
Ghent
Brazil
CCIH - Consultoria em Controle de Infecção Hospitalar Ltda
RECRUITING
Belo Horizonte
Hospital Nossa Senhora das Graças
RECRUITING
Curitiba
CPCLIN - Centro de Estudos e Pesquisas em Molestias Infecciosas - Pesquisa Clínica
RECRUITING
Natal
Hospital de Clinicas de Porto Alegre - UFRGS
RECRUITING
Porto Alegre
Hospital Alemao Oswaldo Cruz
RECRUITING
São Paulo
Bulgaria
UMHAT Burgas AD
RECRUITING
Burgas
Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
RECRUITING
Gorna Oryahovitsa
Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOOD
RECRUITING
Lom
Medicinski centar Hipokrat-N EOOD
RECRUITING
Plovdiv
MHAT Dr.Ivan Seliminski - Sliven Ltd.
RECRUITING
Sliven
Medical Center Excelsior OOD, Base 1
RECRUITING
Sofia
Canada
Alberta Health Services (AHS) - Foothills Medical Centre
RECRUITING
Calgary
INTERMED groupe santé
RECRUITING
Chicoutimi
University of Alberta
RECRUITING
Edmonton
Research St. Josephs Hamilton
RECRUITING
Hamilton
St. Joseph's Hospital - London
RECRUITING
London
The Moncton Hospital
RECRUITING
Moncton
Centre Hospitalier de l Universite Laval (CHUL)
RECRUITING
Québec
CaRe Clinic
RECRUITING
Red Deer
Viable Clinical Research Corporation
RECRUITING
Scarborough Village
NL Health Services
RECRUITING
St. John's
University Health Network
RECRUITING
Toronto
Vancouver Coastal Health Research Institute Clinical Research Unit
RECRUITING
Vancouver
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
France
CHU Bordeaux - Hopital Saint Andre Service de medecine interne et maladies infectieuses
RECRUITING
Bordeaux Cedex
Hôpital du Bocage
RECRUITING
Dijon
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Ile-de-France Ouest - Raymond-Poincare
RECRUITING
Garches
Hospital St. Joseph
RECRUITING
Les Paris
Hôpital De La Croix Rousse - Gastroenterology
RECRUITING
Lyon
CHU de Nantes - Hôtel Dieu
RECRUITING
Nantes
Assistance Publique Hôpitaux de Paris Hôpital Bichat- Claude Bernard - Département des maladies infectieuses et tropicales
RECRUITING
Paris
Centre Hospitalier Universitaire (CHU) de Reims - Hopital Robert Debre
RECRUITING
Paris
Chru De Tours
RECRUITING
Tours
Georgia
ISR-GEO Med Res Clin Healthycore
RECRUITING
Tbilisi
LTD Academician Vakhtang Bochorishvili Clinic
RECRUITING
Tbilisi
LTD Aversi Clinic
RECRUITING
Tbilisi
LTD Emergency Cardiology Center named by Acad.G.Chapidze
RECRUITING
Tbilisi
Germany
Epimed GmbH
RECRUITING
Berlin
University Hospital Cologne AöR - Klinik I für Innere Medizin
RECRUITING
Cologne
University Hospital Frankfurt
RECRUITING
Frankfurt Am Main
Hungary
Bekes Varmegyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
RECRUITING
Békéscsaba
Semmelweis Egyetem
RECRUITING
Budapest
Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház Nyíregyházi Jósa András Tagkórház
RECRUITING
Nyíregyháza
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. sz. Belgyogyaszati Klinika
RECRUITING
Szeged
Komárom-Esztergom Vármegyei Szent Borbála Kórház
RECRUITING
Tatabánya
Ireland
Our Lady of Lourdes Hospital
RECRUITING
Drogheda
Royal College of Surgeons in Ireland - Beaumont Hospital - Education and Research Centre
RECRUITING
Dublin
Israel
The Barzilai Medical Center
RECRUITING
Ashkelon
Hillel Yaffe MC, Clinical Research Unit
RECRUITING
Hadera
Carmel Medical Center
RECRUITING
Haifa
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Centre
RECRUITING
Jerusalem
Rabin Medical Center - Beilinson Hospital
RECRUITING
Petah Tikva
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
The Chaim Sheba Medical Center
RECRUITING
Tel Litwinsky
Shamir Medical Center (Assaf Harofeh)
RECRUITING
Ẕerifin
Italy
AO Nazionale SS. Antonio e Biagio e C. Arrigo
RECRUITING
Alessandria
PO A. Manzoni di Lecco, ASST Lecco
RECRUITING
Lecco
Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
RECRUITING
Milan
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena - Malattie Infettive E Tropicali
RECRUITING
Modena
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Napoli
IRCCS Policlinico San Matteo, Università degli studi di Pavia
RECRUITING
Pavia
AOU Pisana - Stabilimento di Cisanello
RECRUITING
Pisa
Osp. Pediatrico Bambino Gesù, IRCCS
RECRUITING
Roma
Ospedale Isola Tiberina Gemelli Isola
RECRUITING
Roma
Presidio Ospedaliero di Vittorio Veneto
RECRUITING
Vittorio Veneto
Mexico
Centro de Investigacion Medica Aguascalientes
RECRUITING
Aguascalientes
Hospital Cardiologica Aguascalientes - Investigacion
RECRUITING
Aguascalientes
Hospital Universitario Dr. Jose Eleuterio Gonzalez - Infectious Diseases
RECRUITING
Monterrey
Netherlands
Leids Universitair Medisch Centrum (LUMC)
RECRUITING
Leiden
Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
RECRUITING
Utrecht
Poland
Gyncentrum sp. z o.o.
RECRUITING
Katowice
NZOZ VIVAMED Jadwiga Miecz
RECRUITING
Warsaw
Portugal
Unidade Local De Saude De Almada-Seixal E.P.E.
RECRUITING
Almada
CCAB Centro Clinico Academico Braga Associacao - ULS Braga
RECRUITING
Braga
Unidade Local De Saude De Coimbra E.P.E.
RECRUITING
Coimbra
Unidade Local de Saúde da Guarda (ULSG)
RECRUITING
Guarda
Unidade Local De Saude Do Alto Ave E.P.E.
RECRUITING
Guimarães
Unidade Local De Saude De Santo Antonio E.P.E.
RECRUITING
Porto
Unidade Local De Saude De Gaia/Espinho E.P.E.
RECRUITING
Vila Nova De Gaia
Republic of Korea
Hallym University Kangnam Sacred Heart Hospital
RECRUITING
Seoul
Yonsei University, Wonju Severance Christian Hospital
RECRUITING
Wŏnju
Romania
Institutul de Boli Infecțioase Prof Dr Matei Bals - Infectious diseases V
RECRUITING
Bucharest
Spitalul Clinic de Boli Infectioase si Tropicale Dr Victor Babes
RECRUITING
Bucharest
Spitalul Clinic de Boli Infectioase Cluj-Napoca
RECRUITING
Cluj-napoca
Centrul Medical Renasterea
RECRUITING
Craiova
Spitalul Clinic de Boli Infectioase Sfanta Parascheva Iasi - Infectious diseases I
RECRUITING
Iași
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
RECRUITING
Timișoara
Spain
Complexo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital General Universitario Dr Balmis
RECRUITING
Alicante
Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital de La Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario de Bellvitge
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Gregorio Marañón University Hospital
RECRUITING
Madrid
Hospital Universitario La Paz - UCICEC
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Hospital Universitario Puerta De Hierro Majadahonda
RECRUITING
Majadahonda
H. U. Donostia
RECRUITING
San Sebastián
Hospital Universitario Virgen De La Macarena
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitario Mutua de Terrassa
RECRUITING
Terrassa
Taiwan
KMU Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital - Infectious
RECRUITING
Taichung
United Kingdom
The Royal Bournemouth Hospital
RECRUITING
Bournemouth
North Bristol NHS Trust - Southmead Hospital, Clinical Research Centre
RECRUITING
Bristol
NHS Lothian - Western General Hospital
RECRUITING
Edinburgh
Royal Free London NHS Foundation Trust
RECRUITING
London
St.Thomas' Hospital
RECRUITING
London
Northern General Hospital
RECRUITING
Sheffield
Morriston Hospital
RECRUITING
Swansea
Contact Information
Primary
Mary Garfield
Consortium02-ctinquiries@vedantabio.com
857-706-1427
Backup
Steven Shiff, MD
Consortium02-ctinquiries@vedantabio.com
857-706-1427
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2027-10
Participants
Target number of participants: 852
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Vedanta Biosciences, Inc.

This content was sourced from clinicaltrials.gov