Back to Trials
NCT06237452PHASE3Recruiting

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Vedanta Biosciences, Inc.

Start Date

5/20/2024

Completion Date

10/1/2027

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 Criteria

Age Range: 12 years to No maximum

Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population): * Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months Key Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population): * Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI * OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors: 1. Age ≥ 65 years 2. Kidney dysfunction, defined as estimated creatinine clearance \< 60 mL/min/1.73 m\^2 at the time of the qualifying CDI episode 3. History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study 4. History of a prior CDI episode between 6 and 12 months prior to enrollment 5. Immunosuppression due to an underlying disease or its treatment 6. Has undergone solid organ or hematopoietic stem cell transplantation Key Inclusion Criteria (For enrollment in Stage 1 or 2): * The qualifying episode of CDI must meet all the following criteria: 1. New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days 2. CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI 3. Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as enzyme immunoassay (EIA) for toxin A/B and glutamate dehydrogenase (GDH) with polymerase chain reaction (PCR) reflex testing for discordant EIA/GDH results, performed at either a local laboratory or the central laboratory 4. Diarrhea considered unlikely to have another etiology * Prior to receiving any study medication, the participant should: 1. Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible for decentralized participants to be randomized during SoC antibiotic administration. 2. Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, \< 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days * Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing * Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization Key Exclusion Criteria (For both Stage 1 and Stage 2): * History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI * Known or suspected toxic megacolon or small bowel ileus at the time of randomization * History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis * Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode * Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug * Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study) * Probiotics, whether characterized as a dietary/food supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. (Note: consumption of food-based products such as yogurt, kombucha, and kefir are permitted.) * Absolute neutrophil count (ANC) of \< 0.5 ×10\^9 cells/L on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC \< 1.0 × 10\^9 cells/L

Interventions

BIOLOGICAL

VE303

BIOLOGICAL

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Clostridium DifficileClostridium Difficile InfectionsClostridium Difficile Infection RecurrenceClostridioides Difficile InfectionClostridioides Difficile Infection RecurrenceCDIC. Diff InfectionRecurrent Clostridium Difficile InfectionC.Difficile DiarrheaDiarrhea Infectious

Locations

Metro Infectious Disease Consultants

Huntsville, Alabama 35801

United States

Advanced Gastroenterology, P.C.

Chandler, Arizona 85224

United States

Mayo Clinic Hospital

Phoenix, Arizona 85054

United States

GI Alliance

Sun City, Arizona 85351

United States

Om Research, LLC

Apple Valley, California 92307

United States

Science 37 Inc (Remote/Home option)

Culver City, California 90230

United States

Children's Hospital of Los Angeles

Los Angeles, California 90027

United States

VA San Diego Healthcare System

San Diego, California 92161

United States

North America Research Institute

San Dimas, California 91773

United States

Clinical Trials Management Services

Thousand Oaks, California 91360

United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California 90502

United States

Connecticut Clinical Research Institute

Bristol, Connecticut 06010

United States

Medical Research Center of Connecticut

Hamden, Connecticut 06518

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

Gastro Florida

Clearwater, Florida 33756

United States

Proactive Clinical Research, LLC

Fort Lauderdale, Florida 33308

United States

Encore Borland-Groover Clinical Research

Jacksonville, Florida 32256

United States

GI Pros Research

Naples, Florida 34102

United States

Advanced Medical Research Center

Port Orange, Florida 32127

United States

KM International Research Operation LLC

Saint Cloud, Florida 34769

United States

James A. Haley Veterans' Hospital

Tampa, Florida 33612

United States

International Center for Research

Tampa, Florida 33614

United States

Summit Clinical Research, LLC

Athens, Georgia 30607

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Metro Infectious Disease Consultants

Decatur, Georgia 30033

United States

Regional Infectious Diseases and Infusion Center, Inc.

La Grange, Georgia 30240

United States

Gastrointestinal Specialists of Georgia

Marietta, Georgia 30060

United States

Snake River Research, PLLC

Idaho Falls, Idaho 83404

United States

Metro Infectious Disease Consultants

Burr Ridge, Illinois 60527

United States

NorthShore University Health System - Evanston Hospital

Evanston, Illinois 60201

United States

GI Alliance

Gurnee, Illinois 60031

United States

Innovative Clinical Research Center, LLC (ICRC)

Island Lake, Illinois 60042

United States

Indiana University Health University Hospital

Indianapolis, Indiana 46202

United States

Gastroenterology Health Partners

New Albany, Indiana 47150

United States

Deaconess GI Specialty Center

Newburgh, Indiana 47630

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

IDC Clinical Research, LLC

Wichita, Kansas 67211

United States

Gastroenterology Health Partners

Louisville, Kentucky 40218

United States

Ochsner Clinic Foundation

New Orleans, Louisiana 70121

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

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

Chevy Chase, Maryland 20815

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Newton-Wellesley Hospital

Newton, Massachusetts 02462

United States

LTC Charles S. Kettles VA Medical Center

Ann Arbor, Michigan 48105

United States

Henry Ford Health

Detroit, Michigan 48202

United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan 48073

United States

University of Minnesota Medical Center

Minneapolis, Minnesota 55455

United States

MNGI Digestive Health, PA

Plymouth, Minnesota 55446

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Delta Gastroenterology and Endoscopy Center

Southaven, Mississippi 38671

United States

University of Missouri

Columbia, Missouri 65212

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

St. Charles Clinical Research

Weldon Spring, Missouri 63304

United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey 08901

United States

South Jersey Infectious Disease

Somers Point, New Jersey 08244

United States

Northwell Health Division of Infectious Diseases

Manhasset, New York 11030

United States

NYU Grossman School of Medicine

New York, New York 10016

United States

New York Presbyterian Hospital

New York, New York 10021

United States

Manhattan Clinical Research, LLC

New York, New York 10279

United States

Syracuse VA Medical Center

Syracuse, New York 13210

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Toledo Institute of Clinical Research

Toledo, Ohio 43617

United States

Oklahoma City Veterans Affairs Healthcare System

Oklahoma City, Oklahoma 73104

United States

Susquehanna Research Group - Gastroenterology

Harrisburg, Pennsylvania 17110

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Guthrie Medical Group, PC

Sayre, Pennsylvania 18840

United States

Frontier Clinical Research

Uniontown, Pennsylvania 15401

United States

Ralph H. Johnson VA Health Care System

Charleston, South Carolina 29401

United States

Lowcountry Infectious Diseases, P.A.

Charleston, South Carolina 29414

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Gastro One Research

Cordova, Tennessee 38018

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

GI Alliance

Cedar Park, Texas 78613

United States

North Texas Infectious Disease Consultants, P.A.

Dallas, Texas 75246

United States

University of Houston College of Pharmacy

Houston, Texas 77204

United States

BioStar Clinical Research

Katy, Texas 77494

United States

GI Alliance

Lubbock, Texas 79410

United States

Simcare Medical Research, LLC

Sugar Land, Texas 77478

United States

GI Alliance

Richmond, Virginia 23229

United States

Seattle Infectious Disease Clinic

Seattle, Washington 98101

United States

Virginia Mason Medical Center

Seattle, Washington 98101

United States

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin 53207

United States

Concord Repatriation General Hospital

Concord, New South Wales 2139

Australia

Westmead Hospital

Westmead, New South Wales 2148

Australia

Monash Health

Clayton, Victoria 3168

Australia

Melbourne Health

Parkville, Victoria 3050

Australia

Erasme University Hospital - Infectiology Department

Anderlecht, 1070

Belgium

Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc

Brussels, 1200

Belgium

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

CCIH - Consultoria em Controle de Infecção Hospitalar Ltda

Belo Horizonte, Minas Gerais 30150-221

Brazil

Hospital Nossa Senhora das Graças

Curitiba, Paraná 80810-040

Brazil

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

Natal, Rio Grande do Norte 59025-050

Brazil

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

Caxias do Sul, Rio Grande do Sul 95070-561

Brazil

Hospital de Clinicas de Porto Alegre - UFRGS

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

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

Porto Alegre, Rio Grande do Sul 90880-480

Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo 01323-903

Brazil

Medical Center Excelsior OOD, Base 1

Sofia, Sofia-Grad 1407

Bulgaria

UMHAT Burgas AD

Burgas, 8000

Bulgaria

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

Gorna Oryahovitsa, 5100

Bulgaria

Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOOD

Lom, 3600

Bulgaria

Medicinski centar Hipokrat-N EOOD

Plovdiv, 4003

Bulgaria

MHAT Dr.Ivan Seliminski - Sliven Ltd.

Sliven, 8800

Bulgaria

Alberta Health Services (AHS) - Foothills Medical Centre

Calgary, Alberta T2N 2T9

Canada

University of Alberta

Edmonton, Alberta T6G 2X8

Canada

CaRe Clinic

Red Deer, Alberta T4P 1K4

Canada

Vancouver Coastal Health Research Institute Clinical Research Unit

Vancouver, British Columbia V5Z 1M9

Canada

The Moncton Hospital

Moncton, New Brunswick E1C 4B7

Canada

NL Health Services

St. John's, Newfoundland and Labrador A1B3V6

Canada

Research St. Josephs Hamilton

Hamilton, Ontario L8N 4A6

Canada

St. Joseph's Hospital - London

London, Ontario N6A 4V2

Canada

Viable Clinical Research Corporation

Scarborough Village, Ontario M1P 2T7

Canada

University Health Network

Toronto, Ontario M5G 1L7

Canada

INTERMED groupe santé

Chicoutimi, Quebec G7H 7Y8

Canada

Centre Hospitalier de l Universite Laval (CHUL)

Québec, Quebec G1V 4G2

Canada

Fakultni nemocnice Brno

Brno, Brno-město 625 00

Czechia

Nemocnice Kyjov, p.o.

Kyjov, 697 01

Czechia

Fakultni Nemocnice Ostrava

Ostrava-Poruba, 708 52

Czechia

Aarhus University Hospital

Aarhus, Central Jutland 8200

Denmark

Hospital St. Joseph

Les Paris, Auvergne-Rhône-Alpes 75014

France

Hôpital du Bocage

Dijon, Franche-Comté 21079

France

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

Paris, Grand Est 51092 Reims Cedex

France

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

Bordeaux Cedex, Hauts-de-France 33075

France

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

Garches, Hauts-de-Seine 92380

France

CHU de Nantes - Hôtel Dieu

Nantes, Loire-Atlantique 44093

France

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

Paris, Paris 75018

France

Hôpital De La Croix Rousse - Gastroenterology

Lyon, Rhone 69004

France

Chru De Tours

Tours, 37044

France

ISR-GEO Med Res Clin Healthycore

Tbilisi, K'alak'i T'bilisi 0112

Georgia

LTD "Academician Vakhtang Bochorishvili Clinic"

Tbilisi, K'alak'i T'bilisi 0160

Georgia

LTD "Aversi Clinic"

Tbilisi, K'alak'i T'bilisi 0160

Georgia

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

Tbilisi, 0159

Georgia

University Hospital Frankfurt

Frankfurt am Main, Hesse 60590

Germany

University Hospital Cologne AöR - Klinik I für Innere Medizin

Cologne, North Rhine-Westphalia 50937

Germany

Epimed GmbH

Berlin, State of Berlin 12157

Germany

Bekes Varmegyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

Békéscsaba, Bekes County 5600

Hungary

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

Szeged, Csongrád megye H-6725

Hungary

Komárom-Esztergom Vármegyei Szent Borbála Kórház

Tatabánya, Komárom-Esztergom 2800

Hungary

Semmelweis Egyetem

Budapest, 1088

Hungary

Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház Nyíregyházi Jósa András Tagkórház

Nyíregyháza, 4400

Hungary

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

Dublin, Dublin 9

Ireland

Our Lady of Lourdes Hospital

Drogheda, Louth A92 VW28

Ireland

Rabin Medical Center - Beilinson Hospital

Petah Tikva, Central District 4941492

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Central District 64239

Israel

Shamir Medical Center (Assaf Harofeh)

Ẕerifin, Central District 7030000

Israel

Carmel Medical Center

Haifa, Haifa District 34406

Israel

Hillel Yaffe MC, Clinical Research Unit

Hadera, Haifa North 3810101

Israel

Hadassah Medical Centre

Jerusalem, Jerusalem 91120

Israel

The Barzilai Medical Center

Ashkelon, Southern District 7830604

Israel

Rambam Health Care Campus

Haifa, 31096

Israel

The Chaim Sheba Medical Center

Tel Litwinsky, 5265601

Israel

AO Nazionale SS. Antonio e Biagio e C. Arrigo

Alessandria, Alessandria 15121

Italy

PO A. Manzoni di Lecco, ASST Lecco

Lecco, Lombardy 23900

Italy

Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco

Milan, Milano 20157

Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza 20900

Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Napoli 80131

Italy

IRCCS Policlinico San Matteo, Università degli studi di Pavia

Pavia, Pavia 27100

Italy

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

Modena, Reggio Emilia 41124

Italy

Osp. Pediatrico Bambino Gesù, IRCCS

Roma, Roma 00165

Italy

Presidio Ospedaliero di Vittorio Veneto

Vittorio Veneto, Veneto 31029

Italy

AOU Pisana - Stabilimento di Cisanello

Pisa, 56124

Italy

Ospedale Isola Tiberina Gemelli Isola

Roma, 00186

Italy

Centro de Investigacion Medica Aguascalientes

Aguascalientes, Aguascalientes 20116

Mexico

Hospital Cardiologica Aguascalientes - Investigacion

Aguascalientes, Aguascalientes 20230

Mexico

JM Research S.C - Pediatrics

Cuernavaca, Morelos 62290

Mexico

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

Monterrey, Nuevo León 64460

Mexico

FAICIC S de RL de C.V. - Gastroenterology

Veracruz, Veracruz 91900

Mexico

Leids Universitair Medisch Centrum (LUMC)

Leiden, South Holland 2333 ZA

Netherlands

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

Utrecht, 3584 CX

Netherlands

NZOZ VIVAMED Jadwiga Miecz

Warsaw, Masovian Voivodeship 03-580

Poland

Gyncentrum sp. z o.o.

Katowice, Silesian Voivodeship 40-600

Poland

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

Guimarães, Braga District 4835-044

Portugal

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

Coimbra, Coimbra District 3004-591

Portugal

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

Almada, Lisbon District 2805-267

Portugal

CCAB Centro Clinico Academico Braga Associacao - ULS Braga

Braga, 4710-243

Portugal

Unidade Local de Saúde da Guarda (ULSG)

Guarda, 6301-858

Portugal

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

Porto, 4050-011

Portugal

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

Vila Nova de Gaia, 4434-502

Portugal

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

Bucharest, Bucharest 021105

Romania

Spitalul Clinic de Boli Infectioase si Tropicale Dr Victor Babes

Bucharest, Bucharest 030303

Romania

Spitalul Clinic de Boli Infectioase Cluj-Napoca

Cluj-Napoca, Cluj 400348

Romania

Centrul Medical Renasterea

Craiova, Dolj 200073

Romania

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

Iași, Iaşi 700116

Romania

Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara

Timișoara, Timiș County 300723

Romania

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, Gangwon-do 26426

South Korea

Samsung Medical Center

Seoul, Seoul Teugbyeolsi 06351

South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seoul Teugbyeolsi 06591

South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul Teugbyeolsi 07441

South Korea

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona 08916

Spain

Hospital Universitario de Bellvitge

Barcelona, Barcelona 08907

Spain

Hospital Universitario Mutua de Terrassa

Terrassa, Barcelona 08221

Spain

H. U. Donostia

San Sebastián, Guipúzcoa 20014

Spain

Gregorio Marañón University Hospital

Madrid, Madrid 28007

Spain

Hospital Universitario La Paz - UCICEC

Madrid, Madrid 28046

Spain

Hospital Universitario Puerta De Hierro Majadahonda

Majadahonda, Madrid 28222

Spain

Hospital Universitario Virgen Macarena

Seville, Sevilla 41014

Spain

Complexo Hospitalario Universitario A Coruña

A Coruña, 15006

Spain

Hospital General Universitario Dr Balmis

Alicante, 03010

Spain

Hospital Clinic de Barcelona

Barcelona, 08036

Spain

Hospital de La Santa Creu i Sant Pau

Barcelona, 08041

Spain

Hospital Universitario Reina Sofia

Córdoba, 14004

Spain

Hospital Universitario Ramón y Cajal

Madrid, 28034

Spain

Hospital Universitario Virgen De La Macarena

Seville, 41009

Spain

KMU Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung 80756

Taiwan

China Medical University Hospital - Infectious

Taichung, Taichung 404327

Taiwan

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

Taoyuan, Taoyuan 333423

Taiwan

Royal Devon University Healthcare NHS Trust

Exeter, Devon EX2 5DW

United Kingdom

The Royal Bournemouth Hospital

Bournemouth, BH7 7DW

United Kingdom

North Bristol NHS Trust - Southmead Hospital, Clinical Research Centre

Bristol, BS10 5NB

United Kingdom

NHS Lothian - Western General Hospital

Edinburgh, EH4 2XU

United Kingdom

Royal Free London NHS Foundation Trust

London, NW3 2QG

United Kingdom

St.Thomas' Hospital

London, SE1 7EH

United Kingdom

Northern General Hospital

Sheffield, S5 7AU

United Kingdom

Morriston Hospital

Swansea, SA6 6NL

United Kingdom