Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
Ri-CoDIFy 1
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)
1 other identifier
interventional
759
14 countries
149
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2019
Typical duration for phase_3
149 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
July 23, 2018
CompletedStudy Start
First participant enrolled
January 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2021
CompletedResults Posted
Study results publicly available
March 3, 2023
CompletedMarch 3, 2023
March 1, 2023
2.8 years
June 11, 2018
November 16, 2022
March 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
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.
Day 40
Secondary Outcomes (7)
Clinical Response
Day 12
Clinical Cure
Day 12
Sustained Clinical Response Over 60 Days
Day 70
Sustained Clinical Response Over 90 Days
Day 100
Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT.
Day 10
- +2 more secondary outcomes
Study Arms (2)
ridinilazole
EXPERIMENTALridinilazole 200mg bid
vancomycin
ACTIVE COMPARATORvancomycin 125 mg qid
Interventions
ridinilazole (200 mg bid)
Eligibility Criteria
You may qualify if:
- Patients are eligible to be included in the study only if all the following criteria apply:
- Patient must be at least 18 years of age, at the time of signing the informed consent.
- Have signs and symptoms of CDI including diarrhea such that in the Investigator's opinion, CDI antimicrobial therapy is required. Diarrhea is defined as a change in bowel habits, with ≥3 unformed bowel movements (UBMs) (5, 6 or 7 on the Bristol Stool Chart) in the 24 h prior to randomization.
- Have the presence of either toxin A and/or B of C. difficile in the stool determined by a positive free toxin test (using a Sponsor agreed test). The stool sample must be current (produced within 72 hours prior to randomization).
- Male or Female
- Male patients:
- A male patient must agree to use contraception as detailed in Section 10.4 of this protocol during the treatment period and for at least 30 days after the last dose of study treatment and refrain from donating sperm during this period.
- Female patients:
- A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: i. Not a woman of childbearing potential (WOCBP) OR ii. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment.
- Has provided documented signed informed consent and any authorizations required by local law (e.g. Protected Health Information \[PHI\]). If unable to read, understand and sign the informed consent form a legally authorized representative (LAR) may provide consent on the patient's behalf if permitted by the Institutional Review Board (IRB)/Ethics Committee (EC).
You may not qualify if:
- Patients are excluded from the study if any of the following criteria apply:
- Have had more than one prior episode of CDI in the previous 3 months or more than 3 episodes in the past 12 months prior to randomization.
- Have a history of chronic diarrheal disease including inflammatory bowel disease (Crohn's disease or ulcerative colitis).
- Have had a positive diagnostic test for other GI pathogens, considered to be clinically relevant, within 2 weeks of randomization.
- Have had major gastrointestinal (GI) surgery (e.g. significant bowel resection) within 3 months of randomization (this does not include appendectomy). The presence of a colostomy or ileostomy or likely requirement of an ostomy during the study.
- Have life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon.
- History of bone marrow or hematopoietic stem cell transplant at any time or a known current history of a severely compromised/suppressed immune system that, in the opinion of the Investigator, would make the patient unsuitable for the study.
- Have had more than the equivalent of 24 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization. (i.e. more than four doses of oral vancomycin, two doses of fidaxomicin or three doses of metronidazole).
- Prior or current use of anti-toxin antibodies including bezlotoxumab within the past 6 months prior to randomization.
- Are unable to discontinue products used affecting disease progression at randomization.
- Has been involved in a clinical trial and received an investigational medicinal product for indications other than CDI within 1 month or five half-lives (whichever is longer) or within 3 months if the investigational medical product was for CDI.
- Have received an investigational vaccine against C. difficile.
- Patients that the Investigator feels are inappropriate for the study this would include those;
- who, in the opinion of the Investigator, are not likely to complete the study for whatever reason, e.g. short life expectancy.
- with known hypersensitivity or intolerance to ridinilazole, vancomycin, and/or their excipients
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (149)
University of Alabama - Birmingham
Birmingham, Alabama, 35233, United States
GI Alliance - Arizona Digestive Health - Sun City
Sun City, Arizona, 85351, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
Paradigm Clinical Research Centers, Inc
Redding, California, 96601, United States
University Of California Davis
Sacramento, California, 95817, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982, United States
Alliance Medical Research LLC
Lighthouse PT, Florida, 33064, United States
Phoenix Medical Research LLC
Miami, Florida, 33165, United States
San Marcus Research
Miami Lakes, Florida, 33014, United States
Gasteroenterology Group of Naples
Naples, Florida, 31402, United States
HeuerMD Research Inc
Orlando, Florida, 32819, United States
Pines Care Research Center Inc.
Pembroke Pines, Florida, 33026, United States
Bardmoor Gastroenterology
Seminole, Florida, 33777, United States
Professional Health Care of Pinellas
St. Petersburg, Florida, 33713, United States
Florida Medical Clinic P.A.
Zephyrhills, Florida, 33542, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30333, United States
Grand Teton Research Group PLLC
Idaho Falls, Idaho, 83404, United States
GI Alliance - Illinois Gastro Group - Glenview
Glenview, Illinois, 60026, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
UnityPoint Health Peoria/Proctor
Peoria, Illinois, 61603, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
St. Vincent Hospital
Worcester, Massachusetts, 01608-1216, United States
Harper Hospital Department of Pharmacy Services
Detroit, Michigan, 48201-2020, United States
Detroit Receiving Hospital Department of Pharmacy Services
Detroit, Michigan, 48201, United States
Aa Mrc Llc
Flint, Michigan, 48504-4730, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073-6712, United States
Revival Research Institute, LLC.
Southfield, Michigan, 48034, United States
Mercury Street Medical Group PLLC
Butte, Montana, 59701, United States
AB Clinical Trials
Las Vegas, Nevada, 89119, United States
New York Presbyterian Hospital Weill Cornell
New York, New York, 10021, United States
James J. Peters VAMC
The Bronx, New York, 10468, United States
ECU Adult Specialty Care
Greenville, North Carolina, 27834, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Monument Health Clinical Research
Rapid City, South Dakota, 57701, United States
Chattanooga Research and Medicine CHARM
Chattanooga, Tennessee, 37404-3230, United States
GI Alliance - Texas Digestive Disease Consultants - Arlington
Arlington, Texas, 76012, United States
GI Alliance - Texas Digestive Disease Consultants - Cedar Park
Cedar Park, Texas, 78613, United States
DM Clinical Research (Conroe Regional Hospital)
Conroe, Texas, 77304, United States
FMC Science
Lampasas, Texas, 76550, United States
GI Alliance - Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas, 78666, United States
GI Alliance - Texas Digestive Disease Consultants - Webster
Webster, Texas, 77598, United States
Infectious Diseases Associates of Central VA
Lynchburg, Virginia, 24501, United States
Centro Médico Talar
El Talar, Buenos Aires, 1608, Argentina
Instituto Medico Platense
Buenos Aires, BI900AVG, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
Hospital Ramos Mejía
Buenos Aires, C1221ADC, Argentina
Hospital Privado Centro Medico Cordoba
Córdoba, X5016KEH, Argentina
Instituto Medico ALAS
Salta, CP4400, Argentina
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Mater Misericordiae
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Monash Medical Center
Clayton, Victoria, 3168, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Unidade de Pesquisa - NCS - Hospital Felício Rocho
Belo Horizonte, Minas Gerais, 30110-936, Brazil
Hospital Vera Cruz
Belo Horizonte, Minas Gerais, 30140-030, Brazil
Santa Casa De Misericordia De Belo Horizonte
Belo Horizonte, Minas Gerais, 30150221, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020090, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, 90160-092, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, 01327-001, Brazil
MHAT "Sv.Ivan Rilski-2003"OOD
Dupnitsa, Kyustendil, 2600, Bulgaria
"MHAT - Blagoevgrad, EOOD Department of Gastroenterology"
Blagoevgrad, 2700, Bulgaria
DCC1-Sliven Ltd.
Sliven, 8800, Bulgaria
DCC Alexandrovska
Sofia, 1431, Bulgaria
Medical center - Izgrev
Sofia, 1612, Bulgaria
Foothills Medical Centre, South Tower
Calgary, Alberta, T2N 2T9, Canada
Moncton Hospital/Horizon Health Network
Moncton, New Brunswick, E1C 6Z8, Canada
Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 1R9, Canada
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec
Trois-Rivières, Quebec, G8Z 3R9, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec- ULaval
Québec, G1V 4G5, Canada
Recherche Médicale St-Jérôme Inc
Québec, J7Z 5T3, Canada
General Hospital of Athens ''Evangelismos'
Athens, 10676, Greece
General Hospital of Athens ''Alexandra''
Athens, 115-28, Greece
"Pathophysiology Department Athens University Medical School"
Athens, 11527, Greece
" ATTIKON University Hospital"
Athens, 12462, Greece
"'Hygeia'' Hospital 2nd Department of Medicine and Infectious Diseases"
Athens, 15121 Marousi, Greece
University Hospital of Heraklion
Heraklion, 71110, Greece
University Hospital of Patras
Pátrai, 265 04, Greece
''Tzaneio'' General Hospital of Piraeus
Piraeus, 185 -36, Greece
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház, Infektológia-Hepatológia Osztály
Gyula, Bekes County, 5700, Hungary
Pest Megyei Flór Ferenc Kórház, V. Belgyógyászat
Kistarcsa, Pest County, 2143, Hungary
Dr. Kenessey Albert Kórház Rendelőintézet, Tüdőgyógyászati Aktív Osztály
Balassagyarmat, 2660, Hungary
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház IV. Belgyógyászat - 2. Gasztroenterológia
Békéscsaba, 5600, Hungary
"Dél-Pesti Centrumkórház-OHII Szent László Kórház Infektológiai Osztály "
Budapest, H-1097, Hungary
Országos Korányi Pulmonológiai Intézet, Központi Intenzív osztály
Budapest, H-1122, Hungary
CRU Hungary Kft BAZ Megyei Kórház és Egyetemi Oktatókórház, Szent Ferenc Tagkórház
Miskolc, 3529, Hungary
"Pécsi Tudományegyetem I. sz. Belgyógyászat i Klinika, Infektológiai tanszék"
Pécs, H-7623, Hungary
Pécsi Tudományegyetem Klinikai Központi Gyógyszertár
Pécs, H-7624, Hungary
Csongrad County Dr. Bugyi Istvan Hospital, Dept. Of Internal Medicine
Szentes, H-6600, Hungary
Javorszy Odon Hospital
Vác, 2600, Hungary
Waitemata District Health Board WDHB North Shore Hospital
Takapuna, Auckland, 0740, New Zealand
Taranaki District Health Board TDHB - Taranaki Base Hospital
New Plymouth, Taranki, 4310, New Zealand
Waikato District Health Board Waikato Hospital
Hamilton, Waikato Region, 3240, New Zealand
Gabinet Lekarski Bartosz Korczowski
Rzeszów, Podkarpackie Voivodeship, 35-302, Poland
SP ZOZ w Bochni Szpital Powiatowy im. B. Marty Wieckiej
Bochnia, 32-700, Poland
Szpital Bocheński SP ZOZ w Bochni
Bochnia, 32-700, Poland
Klinika Chorób Zakaźnych i Hepatologii Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza
Bydgoszcz, 85-030, Poland
Szpital Specjalistyczny w Chorzowie
Chorzów, 41-500, Poland
Szpital Zakonu Bonifratrów
Katowice, 40-211, Poland
Specjalistyczne Gabinety Sp z o.o.
Krakow, 30-539, Poland
Korczowski Bartosz Gabinet
Rzeszów, 35-302, Poland
ENDOSKOPIA Sp. z o.o.
Sopot, 81-756, Poland
Centralny Szpital Kliniczny MSWiA Klinika Chorób Wewnętrznych i Gastroenterologii
Warsaw, 02-507, Poland
Klinika Chorób Wewnętrznych i Gastroenterologii z Pododdziałem Leczenia Nieswoistych Chorób Zapalnych Jelit Centralny Szpital Kliniczny MSWiA
Warsaw, 02-507, Poland
Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego we Wrocławiu; I Oddział Chorób Zakaźnych
Wroclaw, 51-149, Poland
SUUMC-Boli infectioase
Bucharest, 010825, Romania
Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"
Bucharest, 030303, Romania
S.C. Sana Monitoring Srl
Bucharest, 11025, Romania
Spitalul Clinic de Boli Infectioase si Tropicale
Bucharest, 30303, Romania
Spitalul Minicipal Caracal
Caracal, 235200, Romania
Spitalul Clinic de Boli Infectioase Constanta
Constanța, 900709, Romania
Spitalul Clinic de Boli Infectioase- Sfanta Parascheva
Iași, 700722, Romania
Spitalul Clinic de Boli Infectioase
Iași, 700722, Romania
Spitalul Clinic Judetean de Urgenta Timisoara
Timișoara, 300723, Romania
" State Budgetary Institution of Healthcare "City Clinical Hospital of n.a. V.M.Buyanova" "
Moscow, 115516, Russia
State budget healthcare institution of Novosibirsk region "City clinical hospital #2"
Novosibirsk, 630051, Russia
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253, South Korea
Wonju Severance Christian Hospital
Ilsan-dong, Gangwondo, 26426, South Korea
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 11923, South Korea
Hanyang University Seoul Hospital
Ansan, Seoul, 04763, South Korea
Hallym University Kangnam Sacred Heart Hospital
Anyang-si, Seoul, 07441, South Korea
Kyungpook National University Hospital
Daegu, Seoul, 41944, South Korea
Yeungnam University Medical Center
Daegu, Seoul, 42415, South Korea
Samsung Medical Center
Irwon-dong, Seoul, 06351, South Korea
Keimyung University Dongsan Hospital
Daegu, Yeongnam, 42601, South Korea
Inje University Seoul Paik Hospital
Junggu, 04551, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Kangdong Sacred Heart Hospital
Seoul, 05355, South Korea
Korea University Guro Hospital
Soeul, 08307, South Korea
Asan Medical Center
Soeul, 5505, South Korea
Hospital Universitario Cruces
Barakaldo, 48903, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041, Spain
Hospital Universitario Reina Sofía. Hospital Provincial
Córdoba, 14004, Spain
"Hospital Universtiario Donostia "
Donostia / San Sebastian, 20014, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
"Hospital Universitario Marqués de Valdecilla "
Santander, 39008, Spain
Hospital Universitario de Balme
Seville, 41014, Spain
Hospital Universitari Sant Joan de Reus
Tarragona, 43204, Spain
Related Publications (2)
Okhuysen PC, Ramesh MS, Louie T, Kiknadze N, Torre-Cisneros J, de Oliveira CM, Van Steenkiste C, Stychneuskaya A, Garey KW, Garcia-Diaz J, Li J, Duperchy E, Chang BY, Sukbuntherng J, Montoya JG, Styles L, Clow F, James D, Dubberke ER, Wilcox M. A Randomized, Double-Blind, Phase 3 Safety and Efficacy Study of Ridinilazole Versus Vancomycin for Treatment of Clostridioides difficile Infection: Clinical Outcomes With Microbiome and Metabolome Correlates of Response. Clin Infect Dis. 2024 Jun 14;78(6):1462-1472. doi: 10.1093/cid/ciad792.
PMID: 38305378DERIVEDCarlson TJ, Endres BT, Basseres E, Gonzales-Luna AJ, Garey KW. Ridinilazole for the treatment of Clostridioides difficile infection. Expert Opin Investig Drugs. 2019 Apr;28(4):303-310. doi: 10.1080/13543784.2019.1582640. Epub 2019 Feb 26.
PMID: 30767587DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Katie Tran
- Organization
- Summit Therapeutics
Study Officials
- STUDY DIRECTOR
Lori Styles, MD
Summit Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- In both arms patients receive the same number of doses per day. Placebo tablets are included to maintain same number and appearance of IP in both arms.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2018
First Posted
July 23, 2018
Study Start
January 28, 2019
Primary Completion
November 17, 2021
Study Completion
November 17, 2021
Last Updated
March 3, 2023
Results First Posted
March 3, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share