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COMPLETED
NCT03595553
PHASE3

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

Sponsor: Summit Therapeutics

View on ClinicalTrials.gov

Summary

Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects treated with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin. Ridinilazole plasma concentration will be assessed in a subset of patients.

Official title: A Phase 3, Randomized, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Ridinilazole (200 mg, Bid) for 10 Days With Vancomycin (125 mg, Qid) for 10 Days in the Treatment of Clostridium Difficile Infection (CDI)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

759

Start Date

2019-01-28

Completion Date

2021-11-17

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

DRUG

Ridinilazole

ridinilazole (200 mg bid)

DRUG

Vancomycin

vancomycin (125 mg qid)

Locations (149)

University of Alabama - Birmingham

Birmingham, Alabama, United States

GI Alliance - Arizona Digestive Health - Sun City

Sun City, Arizona, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Facey Medical Foundation

Mission Hills, California, United States

Paradigm Clinical Research Centers, Inc

Redding, California, United States

University Of California Davis

Sacramento, California, United States

Midway Immunology and Research Center

Ft. Pierce, Florida, United States

Alliance Medical Research LLC

Lighthouse PT, Florida, United States

Phoenix Medical Research LLC

Miami, Florida, United States

San Marcus Research

Miami Lakes, Florida, United States

Gasteroenterology Group of Naples

Naples, Florida, United States

HeuerMD Research Inc

Orlando, Florida, United States

Pines Care Research Center Inc.

Pembroke Pines, Florida, United States

Bardmoor Gastroenterology

Seminole, Florida, United States

Professional Health Care of Pinellas

St. Petersburg, Florida, United States

Florida Medical Clinic P.A.

Zephyrhills, Florida, United States

Infectious Disease Specialists of Atlanta

Decatur, Georgia, United States

Grand Teton Research Group PLLC

Idaho Falls, Idaho, United States

GI Alliance - Illinois Gastro Group - Glenview

Glenview, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

UnityPoint Health Peoria/Proctor

Peoria, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Carle Foundation Hospital

Urbana, Illinois, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

St. Vincent Hospital

Worcester, Massachusetts, United States

Harper Hospital Department of Pharmacy Services

Detroit, Michigan, United States

Detroit Receiving Hospital Department of Pharmacy Services

Detroit, Michigan, United States

Aa Mrc Llc

Flint, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Revival Research Institute, LLC.

Southfield, Michigan, United States

Mercury Street Medical Group PLLC

Butte, Montana, United States

AB Clinical Trials

Las Vegas, Nevada, United States

New York Presbyterian Hospital Weill Cornell

New York, New York, United States

James J. Peters VAMC

The Bronx, New York, United States

ECU Adult Specialty Care

Greenville, North Carolina, United States

PMG Research of Winston-Salem

Winston-Salem, North Carolina, United States

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Monument Health Clinical Research

Rapid City, South Dakota, United States

Chattanooga Research and Medicine CHARM

Chattanooga, Tennessee, United States

GI Alliance - Texas Digestive Disease Consultants - Arlington

Arlington, Texas, United States

GI Alliance - Texas Digestive Disease Consultants - Cedar Park

Cedar Park, Texas, United States

DM Clinical Research (Conroe Regional Hospital)

Conroe, Texas, United States

FMC Science

Lampasas, Texas, United States

GI Alliance - Texas Digestive Disease Consultants - San Marcos

San Marcos, Texas, United States

GI Alliance - Texas Digestive Disease Consultants - Webster

Webster, Texas, United States

Infectious Diseases Associates of Central VA

Lynchburg, Virginia, United States

Instituto Medico ALAS

Salta, Argentina, Argentina

Centro Médico Talar

El Talar, Buenos Aires, Argentina

Instituto Medico Platense

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Hospital Ramos Mejía

Buenos Aires, Argentina

Hospital Privado Centro Medico Cordoba

Córdoba, Argentina

Westmead Hospital

Westmead, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Mater Misericordiae

South Brisbane, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Monash Medical Center

Clayton, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Unidade de Pesquisa - NCS - Hospital Felício Rocho

Belo Horizonte, Minas Gerais, Brazil

Hospital Vera Cruz

Belo Horizonte, Minas Gerais, Brazil

Santa Casa De Misericordia De Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, Brazil

MHAT "Sv.Ivan Rilski-2003"OOD

Dupnitsa, Kyustendil, Bulgaria

DCC1-Sliven Ltd.

Sliven, Sliven, Bulgaria

DCC Alexandrovska

Sofia, Sofia, Bulgaria

"MHAT - Blagoevgrad, EOOD Department of Gastroenterology"

Blagoevgrad, Bulgaria

Medical center - Izgrev

Sofia, Bulgaria

Foothills Medical Centre, South Tower

Calgary, Alberta, Canada

Moncton Hospital/Horizon Health Network

Moncton, New Brunswick, Canada

Lakeridge Health

Oshawa, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec- ULaval

Québec, Quebec, Canada

Recherche Médicale St-Jérôme Inc

Québec, Quebec, Canada

Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec

Trois-Rivières, Quebec, Canada

General Hospital of Athens ''Evangelismos'

Athens, Greece

General Hospital of Athens ''Alexandra''

Athens, Greece

"Pathophysiology Department Athens University Medical School"

Athens, Greece

" ATTIKON University Hospital"

Athens, Greece

"'Hygeia'' Hospital 2nd Department of Medicine and Infectious Diseases"

Athens, Greece

University Hospital of Heraklion

Heraklion, Greece

University Hospital of Patras

Pátrai, Greece

''Tzaneio'' General Hospital of Piraeus

Piraeus, Greece

Békés Megyei Központi Kórház Pándy Kálmán Tagkórház, Infektológia-Hepatológia Osztály

Gyula, Bekes County, Hungary

Pest Megyei Flór Ferenc Kórház, V. Belgyógyászat

Kistarcsa, Pest County, Hungary

Javorszy Odon Hospital

Vác, Vác, Hungary

Dr. Kenessey Albert Kórház Rendelőintézet, Tüdőgyógyászati Aktív Osztály

Balassagyarmat, Hungary

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház IV. Belgyógyászat - 2. Gasztroenterológia

Békéscsaba, Hungary

"Dél-Pesti Centrumkórház-OHII Szent László Kórház Infektológiai Osztály "

Budapest, Hungary

Országos Korányi Pulmonológiai Intézet, Központi Intenzív osztály

Budapest, Hungary

CRU Hungary Kft BAZ Megyei Kórház és Egyetemi Oktatókórház, Szent Ferenc Tagkórház

Miskolc, Hungary

"Pécsi Tudományegyetem I. sz. Belgyógyászat i Klinika, Infektológiai tanszék"

Pécs, Hungary

Pécsi Tudományegyetem Klinikai Központi Gyógyszertár

Pécs, Hungary

Csongrad County Dr. Bugyi Istvan Hospital, Dept. Of Internal Medicine

Szentes, Hungary

Waitemata District Health Board WDHB North Shore Hospital

Takapuna, Auckland, New Zealand

Taranaki District Health Board TDHB - Taranaki Base Hospital

New Plymouth, Taranki, New Zealand

Waikato District Health Board Waikato Hospital

Hamilton, Waikato Region, New Zealand

Gabinet Lekarski Bartosz Korczowski

Rzeszów, Podkarpackie Voivodeship, Poland

SP ZOZ w Bochni Szpital Powiatowy im. B. Marty Wieckiej

Bochnia, Poland

Szpital Bocheński SP ZOZ w Bochni

Bochnia, Poland

Klinika Chorób Zakaźnych i Hepatologii Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza

Bydgoszcz, Poland

Szpital Specjalistyczny w Chorzowie

Chorzów, Poland

Szpital Zakonu Bonifratrów

Katowice, Poland

Specjalistyczne Gabinety Sp z o.o.

Krakow, Poland

Korczowski Bartosz Gabinet

Rzeszów, Poland

ENDOSKOPIA Sp. z o.o.

Sopot, Poland

Centralny Szpital Kliniczny MSWiA Klinika Chorób Wewnętrznych i Gastroenterologii

Warsaw, Poland

Klinika Chorób Wewnętrznych i Gastroenterologii z Pododdziałem Leczenia Nieswoistych Chorób Zapalnych Jelit Centralny Szpital Kliniczny MSWiA

Warsaw, Poland

Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego we Wrocławiu; I Oddział Chorób Zakaźnych

Wroclaw, Poland

SUUMC-Boli infectioase

Bucharest, Romania

Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"

Bucharest, Romania

S.C. Sana Monitoring Srl

Bucharest, Romania

Spitalul Clinic de Boli Infectioase si Tropicale

Bucharest, Romania

Spitalul Minicipal Caracal

Caracal, Romania

Spitalul Clinic de Boli Infectioase Constanta

Constanța, Romania

Spitalul Clinic de Boli Infectioase- Sfanta Parascheva

Iași, Romania

Spitalul Clinic de Boli Infectioase

Iași, Romania

Spitalul Clinic Judetean de Urgenta Timisoara

Timișoara, Romania

" State Budgetary Institution of Healthcare "City Clinical Hospital of n.a. V.M.Buyanova" "

Moscow, Russia

State budget healthcare institution of Novosibirsk region "City clinical hospital #2"

Novosibirsk, Russia

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Wonju Severance Christian Hospital

Ilsan-dong, Gangwondo, South Korea

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Hanyang University Seoul Hospital

Ansan, Seoul, South Korea

Hallym University Kangnam Sacred Heart Hospital

Anyang-si, Seoul, South Korea

Kyungpook National University Hospital

Daegu, Seoul, South Korea

Yeungnam University Medical Center

Daegu, Seoul, South Korea

Samsung Medical Center

Irwon-dong, Seoul, South Korea

Keimyung University Dongsan Hospital

Daegu, Yeongnam, South Korea

Inje University Seoul Paik Hospital

Junggu, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Kangdong Sacred Heart Hospital

Seoul, South Korea

Korea University Guro Hospital

Soeul, South Korea

Asan Medical Center

Soeul, South Korea

Hospital Universitario de Balme

Seville, Sevilla, Spain

Hospital Universitario Cruces

Barakaldo, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Reina Sofía. Hospital Provincial

Córdoba, Spain

"Hospital Universtiario Donostia "

Donostia / San Sebastian, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

"Hospital Universitario Marqués de Valdecilla "

Santander, Spain

Hospital Universitari Sant Joan de Reus

Tarragona, Spain