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Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
Sponsor: Summit Therapeutics
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
Conditions
Interventions
Ridinilazole
ridinilazole (200 mg bid)
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