Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
- Conditions
- Clostridioides Difficile Infection
- Interventions
- Registration Number
- NCT03595553
- Lead Sponsor
- Summit Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 759
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vancomycin Vancomycin vancomycin 125 mg qid ridinilazole Ridinilazole ridinilazole 200mg bid
- Primary Outcome Measures
Name Time Method Number of Participants With Sustained Clinical Response (SCR) Defined as Clinical Response and no Recurrence of CDI Through 30 Days Post End of Treatment (EOT). Day 40 This primary outcome measures the number of participants with Sustained Clinical Response (SCR). SCR is defined as Clinical Response and no recurrence of CDI through 30 days post End of Treatment (EOT). At D40, D70 and D100 the Investigator or medically qualified designee will determine if the patient has a sustained clinical response or experienced RECURRENCE since the previous assessment. The Investigator will assess cure/failure and recurrence based on available information which includes, but is not limited to, improvement from baseline in the number of UBMs, signs \& symptoms of CDI, and the requirement for CDI medication. The Investigator should assess cure/failure in a way that best reflects the Investigator's standard clinical practice.
- Secondary Outcome Measures
Name Time Method Clinical Response Day 12 defined as
* less than 3 unformed bowel movements (UBMs) for consecutive days and maintained through EOT without further CDI treatment at EOT + 2 days, or
* the investigator's assessment that the subject no longer needs specific CDI antimicrobial treatment after completion of the course of study medication.Clinical Cure Day 12 defined as the resolution of diarrhea (\<3 UBMs in the 1-day period immediately prior to EOT, that is maintained for 2 days after EOT).
Sustained Clinical Response Over 60 Days Day 70 defined as Clinical Response and no recurrence of CDI through 60 days post EOT
Sustained Clinical Response Over 90 Days Day 100 defined as Clinical Response and no recurrence of CDI through 90 days post EOT
Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT. Day 10 This secondary outcome measures the relative abundance of the 3 main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) from Baseline to EOT.
Percentage of Change of α-diversity (Shannon Index) of the Microbiota in Stool Samples From Baseline to EOT. Day 10 This secondary outcome measures the percentage of change of α-diversity (Shannon Index) of the microbiota in stool samples from baseline to EOT. Shannon index is a weighted statistic measuring both species richness and evenness. The Shannon Index is calculated by taking the relative abundance of each species and sums the relative abundance times the natural log of the relative abundance for each species. The value is converted into a positive value by times minus one. A higher Shannon Index means higher diversity
Measure of β-diversity of the Gut Microbiota Between Baseline and EOT Stool Samples (Bray-Curtis Index/Dissimilarity). Day 10 This secondary outcome measures the β-diversity of the gut microbiota in stool samples from baseline to EOT. Bray-Curtis index/dissimilarity measures how different two samples are in the microbiome composition. The Bray-Curtis dissimilarity is graded between 0 and 1, where 0 means the two samples have the same composition (that is they share all the species and every species has the same abundance), and 1 means the two samples do not share any species.
Trial Locations
- Locations (149)
DCC1-Sliven Ltd.
🇧🇬Sliven, Bulgaria
''Tzaneio'' General Hospital of Piraeus
🇬🇷Piraeus, Greece
Dr. Kenessey Albert Kórház Rendelőintézet, Tüdőgyógyászati Aktív Osztály
🇭🇺Balassagyarmat, Hungary
Csongrad County Dr. Bugyi Istvan Hospital, Dept. Of Internal Medicine
🇭🇺Szentes, Hungary
Országos Korányi Pulmonológiai Intézet, Központi Intenzív osztály
🇭🇺Budapest, Hungary
Klinika Chorób Zakaźnych i Hepatologii Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza
🇵🇱Bydgoszcz, Poland
Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego we Wrocławiu; I Oddział Chorób Zakaźnych
🇵🇱Wroclaw, Poland
SUUMC-Boli infectioase
🇷🇴Bucuresti, Romania
Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"
🇷🇴Bucuresti, Romania
Szpital Specjalistyczny w Chorzowie
🇵🇱Chorzów, Poland
Spitalul Clinic de Boli Infectioase Constanta
🇷🇴Constanta, Romania
Spitalul Clinic de Boli Infectioase- Sfanta Parascheva
🇷🇴Iasi, Romania
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Moncton Hospital/Horizon Health Network
🇨🇦Moncton, New Brunswick, Canada
Phoenix Medical Research LLC
🇺🇸Miami, Florida, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Hospital Ernesto Dornelles
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Vera Cruz
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Santa Casa De Misericordia De Belo Horizonte
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Unidade de Pesquisa - NCS - Hospital Felício Rocho
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
AB Clinical Trials
🇺🇸Las Vegas, Nevada, United States
ECU Adult Specialty Care
🇺🇸Greenville, North Carolina, United States
Monument Health Clinical Research
🇺🇸Rapid City, South Dakota, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
GI Alliance - Texas Digestive Disease Consultants - San Marcos
🇺🇸San Marcos, Texas, United States
Centro Médico Talar
🇦🇷El Talar, Buenos Aires, Argentina
Hospital Alemao Oswaldo Cruz
🇧🇷Sao Paulo, Brazil
Monash Medical Center
🇦🇺Clayton, Victoria, Australia
Hospital das Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Mater Misericordiae
🇦🇺South Brisbane, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
MHAT "Sv.Ivan Rilski-2003"OOD
🇧🇬Dupnitsa, Kyustendil, Bulgaria
"MHAT - Blagoevgrad, EOOD Department of Gastroenterology"
🇧🇬Blagoevgrad, Bulgaria
General Hospital of Athens ''Evangelismos'
🇬🇷Athens, Greece
University Hospital of Patras
🇬🇷Patras, Greece
Medical center - Izgrev
🇧🇬Sofia, Bulgaria
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montréal, Quebec, Canada
"Pathophysiology Department Athens University Medical School"
🇬🇷Athens, Greece
"'Hygeia'' Hospital 2nd Department of Medicine and Infectious Diseases"
🇬🇷Athens, Greece
Pest Megyei Flór Ferenc Kórház, V. Belgyógyászat
🇭🇺Kistarcsa, Pest Megye, Hungary
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház, Infektológia-Hepatológia Osztály
🇭🇺Gyula, Békés, Hungary
Javorszy Odon Hospital
🇭🇺Vác, Hungary
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Anyang-si, Seoul, Korea, Republic of
SP ZOZ w Bochni Szpital Powiatowy im. B. Marty Wieckiej
🇵🇱Bochnia, Poland
Specjalistyczne Gabinety Sp z o.o.
🇵🇱Krakow, Poland
Waikato District Health Board Waikato Hospital
🇳🇿Hamilton, Waikato, New Zealand
Asan Medical Center
🇰🇷Soeul, Korea, Republic of
Szpital Bocheński SP ZOZ w Bochni
🇵🇱Bochnia, Poland
Spitalul Minicipal Caracal
🇷🇴Caracal, Romania
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
Hospital Universitario Reina Sofía. Hospital Provincial
🇪🇸Córdoba, Spain
Lakeridge Health
🇨🇦Oshawa, Ontario, Canada
Foothills Medical Centre, South Tower
🇨🇦Calgary, Alberta, Canada
Recherche Médicale St-Jérôme Inc
🇨🇦Quebec, Canada
University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Infectious Disease Specialists of Atlanta
🇺🇸Decatur, Georgia, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Hallym University Chuncheon Sacred Heart Hospital
🇰🇷Chuncheon, Gangwon-do, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri-Si, Gyeonggi-do, Korea, Republic of
Hospital Ramos Mejía
🇦🇷Buenos Aires, Argentina
Instituto Medico ALAS
🇦🇷Salta, Argentina
Gasteroenterology Group of Naples
🇺🇸Naples, Florida, United States
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
🇧🇷Sao Jose do Rio Preto, Sao Paulo, Brazil
GI Alliance - Arizona Digestive Health - Sun City
🇺🇸Sun City, Arizona, United States
Facey Medical Foundation
🇺🇸Mission Hills, California, United States
Midway Immunology and Research Center
🇺🇸Fort Pierce, Florida, United States
University Of California Davis
🇺🇸Sacramento, California, United States
Alliance Medical Research LLC
🇺🇸Lighthouse Point, Florida, United States
Paradigm Clinical Research Centers, Inc
🇺🇸Redding, California, United States
San Marcus Research
🇺🇸Miami Lakes, Florida, United States
Pines Care Research Center Inc.
🇺🇸Pembroke Pines, Florida, United States
Professional Health Care of Pinellas
🇺🇸Saint Petersburg, Florida, United States
Bardmoor Gastroenterology
🇺🇸Seminole, Florida, United States
Florida Medical Clinic P.A.
🇺🇸Zephyrhills, Florida, United States
GI Alliance - Illinois Gastro Group - Glenview
🇺🇸Glenview, Illinois, United States
Grand Teton Research Group PLLC
🇺🇸Idaho Falls, Idaho, United States
UnityPoint Health Peoria/Proctor
🇺🇸Peoria, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
St. Vincent Hospital
🇺🇸Worcester, Massachusetts, United States
Detroit Receiving Hospital Department of Pharmacy Services
🇺🇸Detroit, Michigan, United States
Aa Mrc Llc
🇺🇸Flint, Michigan, United States
Harper Hospital Department of Pharmacy Services
🇺🇸Detroit, 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
James J. Peters VAMC
🇺🇸Bronx, New York, United States
New York Presbyterian Hospital Weill Cornell
🇺🇸New York, New York, United States
Chattanooga Research and Medicine CHARM
🇺🇸Chattanooga, Tennessee, United States
GI Alliance - Texas Digestive Disease Consultants - Arlington
🇺🇸Arlington, Texas, United States
FMC Science
🇺🇸Lampasas, Texas, United States
GI Alliance - Texas Digestive Disease Consultants - Webster
🇺🇸Webster, Texas, United States
Instituto Medico Platense
🇦🇷Buenos Aires, Argentina
Infectious Diseases Associates of Central VA
🇺🇸Lynchburg, Virginia, United States
Hospital Privado Centro Medico Cordoba
🇦🇷Cordoba, Argentina
Sunshine Coast University Hospital
🇦🇺Birtinya, Queensland, Australia
DCC Alexandrovska
🇧🇬Sofia, Bulgaria
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec
🇨🇦Trois-Rivières, Quebec, Canada
" ATTIKON University Hospital"
🇬🇷Athens, Greece
Institut Universitaire de Cardiologie et de Pneumologie de Québec- ULaval
🇨🇦Quebec, Canada
General Hospital of Athens ''Alexandra''
🇬🇷Athens, Greece
University Hospital of Heraklion
🇬🇷Heraklion, Greece
"Dél-Pesti Centrumkórház-OHII Szent László Kórház Infektológiai Osztály "
🇭🇺Budapest, Hungary
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház IV. Belgyógyászat - 2. Gasztroenterológia
🇭🇺Békéscsaba, Hungary
Pécsi Tudományegyetem Klinikai Központi Gyógyszertár
🇭🇺Pécs, 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
Wonju Severance Christian Hospital
🇰🇷Ilsan-dong, Gangwondo, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan-si, Gyeonggi-do, Korea, Republic of
Samsung Medical Center
🇰🇷Irwon-dong, Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Ansan, Seoul, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Yeongnam, Korea, Republic of
Inje University Seoul Paik Hospital
🇰🇷Junggu, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Soeul, Korea, Republic of
Gabinet Lekarski Bartosz Korczowski
🇵🇱Rzeszów, Podkarpackie, Poland
Szpital Zakonu Bonifratrów
🇵🇱Katowice, Poland
Korczowski Bartosz Gabinet
🇵🇱Rzeszow, Poland
ENDOSKOPIA Sp. z o.o.
🇵🇱Sopot, Poland
Centralny Szpital Kliniczny MSWiA Klinika Chorób Wewnętrznych i Gastroenterologii
🇵🇱Warszawa, Poland
Klinika Chorób Wewnętrznych i Gastroenterologii z Pododdziałem Leczenia Nieswoistych Chorób Zapalnych Jelit Centralny Szpital Kliniczny MSWiA
🇵🇱Warszawa, Poland
Spitalul Clinic de Boli Infectioase si Tropicale
🇷🇴Bucuresti, Romania
S.C. Sana Monitoring Srl
🇷🇴Bucuresti, Romania
Spitalul Clinic de Boli Infectioase
🇷🇴Iaşi, Romania
Spitalul Clinic Judetean de Urgenta Timisoara
🇷🇴Timișoara, Romania
" State Budgetary Institution of Healthcare "City Clinical Hospital of n.a. V.M.Buyanova" "
🇷🇺Moscow, Russian Federation
State budget healthcare institution of Novosibirsk region "City clinical hospital #2"
🇷🇺Novosibirsk, Russian Federation
Hospital Universitario Cruces
🇪🇸Barakaldo, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
"Hospital Universitario Marqués de Valdecilla "
🇪🇸Santander, Spain
"Hospital Universtiario Donostia "
🇪🇸Donostia, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario de Balme
🇪🇸Sevilla, Spain
Hospital Universitari Sant Joan de Reus
🇪🇸Tarragona, Spain
Yeungnam University Medical Center
🇰🇷Daegu, Seoul, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Seoul, Korea, Republic of
HeuerMD Research Inc
🇺🇸Orlando, Florida, United States
PMG Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
DM Clinical Research (Conroe Regional Hospital)
🇺🇸Conroe, Texas, United States
GI Alliance - Texas Digestive Disease Consultants - Cedar Park
🇺🇸Cedar Park, Texas, United States