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Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection (Ri-CoDIFy 1)

Primary Purpose

Clostridioides Difficile Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ridinilazole
Vancomycin
Sponsored by
Summit Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridioides Difficile Infection focused on measuring Clostridioides difficile, Clostridium difficile, C. difficile, C. diff

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Patients are eligible to be included in the study only if all the following criteria apply:

  1. Patient must be at least 18 years of age, at the time of signing the informed consent.
  2. 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.
  3. 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).

  4. 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.

  5. 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).

Exclusion Criteria

Patients are excluded from the study if any of the following criteria apply:

  1. 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.
  2. Have a history of chronic diarrheal disease including inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  3. Have had a positive diagnostic test for other GI pathogens, considered to be clinically relevant, within 2 weeks of randomization.
  4. 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.
  5. Have life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon.
  6. 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.
  7. 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).
  8. Prior or current use of anti-toxin antibodies including bezlotoxumab within the past 6 months prior to randomization.
  9. Are unable to discontinue products used affecting disease progression at randomization.
  10. 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.
  11. Have received an investigational vaccine against C. difficile.

  12. Patients that the Investigator feels are inappropriate for the study this would include those;

    1. with any other condition that, in the Investigator's judgment, would make the patient unsuitable for inclusion in the study.
    2. who, in the opinion of the Investigator, are not likely to complete the study for whatever reason, e.g. short life expectancy.
    3. with known hypersensitivity or intolerance to ridinilazole, vancomycin, and/or their excipients
    4. who are unwilling or unable to comply with protocol requirements, e.g. complete the full course of study treatment per schedule, attend study visits, report diarrhea/suspected recurrence, provide stool samples, ingest capsules/tablets or blood draws.

Sites / Locations

  • University of Alabama - Birmingham
  • GI Alliance - Arizona Digestive Health - Sun City
  • David Geffen School of Medicine at UCLA
  • Facey Medical Foundation
  • Paradigm Clinical Research Centers, Inc
  • University Of California Davis
  • Midway Immunology and Research Center
  • Alliance Medical Research LLC
  • San Marcus Research
  • Phoenix Medical Research LLC
  • Gasteroenterology Group of Naples
  • HeuerMD Research Inc
  • Pines Care Research Center Inc.
  • Professional Health Care of Pinellas
  • Bardmoor Gastroenterology
  • Florida Medical Clinic P.A.
  • Infectious Disease Specialists of Atlanta
  • Grand Teton Research Group PLLC
  • GI Alliance - Illinois Gastro Group - Glenview
  • Loyola University Medical Center
  • UnityPoint Health Peoria/Proctor
  • Southern Illinois University School of Medicine
  • Carle Foundation Hospital
  • The University of Kansas Medical Center
  • Ochsner Clinic Foundation
  • University of Maryland School of Medicine
  • St. Vincent Hospital
  • Harper Hospital Department of Pharmacy Services
  • Detroit Receiving Hospital Department of Pharmacy Services
  • Aa Mrc Llc
  • William Beaumont Hospital
  • Revival Research Institute, LLC.
  • Mercury Street Medical Group PLLC
  • AB Clinical Trials
  • James J. Peters VAMC
  • New York Presbyterian Hospital Weill Cornell
  • ECU Adult Specialty Care
  • PMG Research of Winston-Salem
  • St. Vincent Mercy Medical Center
  • University of Pittsburgh Medical Center
  • Monument Health Clinical Research
  • Chattanooga Research and Medicine CHARM
  • GI Alliance - Texas Digestive Disease Consultants - Arlington
  • GI Alliance - Texas Digestive Disease Consultants - Cedar Park
  • DM Clinical Research (Conroe Regional Hospital)
  • FMC Science
  • GI Alliance - Texas Digestive Disease Consultants - San Marcos
  • GI Alliance - Texas Digestive Disease Consultants - Webster
  • Infectious Diseases Associates of Central VA
  • Centro Médico Talar
  • Instituto Medico Platense
  • Hospital Italiano de Buenos Aires
  • Hospital Ramos Mejía
  • Hospital Privado Centro Medico Cordoba
  • Instituto Medico ALAS
  • Westmead Hospital
  • Sunshine Coast University Hospital
  • Mater Misericordiae
  • Princess Alexandra Hospital
  • Monash Medical Center
  • Fiona Stanley Hospital
  • Unidade de Pesquisa - NCS - Hospital Felício Rocho
  • Hospital Vera Cruz
  • Santa Casa De Misericordia De Belo Horizonte
  • Santa Casa de Misericordia de Porto Alegre
  • Hospital das Clinicas de Porto Alegre
  • Hospital Ernesto Dornelles
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • Hospital Alemao Oswaldo Cruz
  • MHAT "Sv.Ivan Rilski-2003"OOD
  • "MHAT - Blagoevgrad, EOOD Department of Gastroenterology"
  • DCC1-Sliven Ltd.
  • DCC Alexandrovska
  • Medical center - Izgrev
  • Foothills Medical Centre, South Tower
  • Moncton Hospital/Horizon Health Network
  • Lakeridge Health
  • Centre Hospitalier de l'Universite de Montreal
  • Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec- ULaval
  • Recherche Médicale St-Jérôme Inc
  • General Hospital of Athens ''Evangelismos'
  • General Hospital of Athens ''Alexandra''
  • "Pathophysiology Department Athens University Medical School"
  • " ATTIKON University Hospital"
  • "'Hygeia'' Hospital 2nd Department of Medicine and Infectious Diseases"
  • University Hospital of Heraklion
  • University Hospital of Patras
  • ''Tzaneio'' General Hospital of Piraeus
  • Békés Megyei Központi Kórház Pándy Kálmán Tagkórház, Infektológia-Hepatológia Osztály
  • Pest Megyei Flór Ferenc Kórház, V. Belgyógyászat
  • Dr. Kenessey Albert Kórház Rendelőintézet, Tüdőgyógyászati Aktív Osztály
  • "Dél-Pesti Centrumkórház-OHII Szent László Kórház Infektológiai Osztály "
  • Országos Korányi Pulmonológiai Intézet, Központi Intenzív osztály
  • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház IV. Belgyógyászat - 2. Gasztroenterológia
  • CRU Hungary Kft BAZ Megyei Kórház és Egyetemi Oktatókórház, Szent Ferenc Tagkórház
  • "Pécsi Tudományegyetem I. sz. Belgyógyászat i Klinika, Infektológiai tanszék"
  • Pécsi Tudományegyetem Klinikai Központi Gyógyszertár
  • Csongrad County Dr. Bugyi Istvan Hospital, Dept. Of Internal Medicine
  • Javorszy Odon Hospital
  • Hallym University Chuncheon Sacred Heart Hospital
  • Wonju Severance Christian Hospital
  • Korea University Ansan Hospital
  • Hanyang University Guri Hospital
  • Hanyang University Seoul Hospital
  • Hallym University Kangnam Sacred Heart Hospital
  • Kyungpook National University Hospital
  • Yeungnam University Medical Center
  • Samsung Medical Center
  • Keimyung University Dongsan Hospital
  • Inje University Seoul Paik Hospital
  • Kangbuk Samsung Hospital
  • Kangdong Sacred Heart Hospital
  • Korea University Guro Hospital
  • Asan Medical Center
  • Waitemata District Health Board WDHB North Shore Hospital
  • Taranaki District Health Board TDHB - Taranaki Base Hospital
  • Waikato District Health Board Waikato Hospital
  • Gabinet Lekarski Bartosz Korczowski
  • SP ZOZ w Bochni Szpital Powiatowy im. B. Marty Wieckiej
  • Szpital Bocheński SP ZOZ w Bochni
  • Klinika Chorób Zakaźnych i Hepatologii Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza
  • Szpital Specjalistyczny w Chorzowie
  • Szpital Zakonu Bonifratrów
  • Specjalistyczne Gabinety Sp z o.o.
  • Korczowski Bartosz Gabinet
  • ENDOSKOPIA Sp. z o.o.
  • Centralny Szpital Kliniczny MSWiA Klinika Chorób Wewnętrznych i Gastroenterologii
  • Klinika Chorób Wewnętrznych i Gastroenterologii z Pododdziałem Leczenia Nieswoistych Chorób Zapalnych Jelit Centralny Szpital Kliniczny MSWiA
  • Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego we Wrocławiu; I Oddział Chorób Zakaźnych
  • SUUMC-Boli infectioase
  • Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"
  • S.C. Sana Monitoring Srl
  • Spitalul Clinic de Boli Infectioase si Tropicale
  • Spitalul Minicipal Caracal
  • Spitalul Clinic de Boli Infectioase Constanta
  • Spitalul Clinic de Boli Infectioase- Sfanta Parascheva
  • Spitalul Clinic de Boli Infectioase
  • Spitalul Clinic Judetean de Urgenta Timisoara
  • " State Budgetary Institution of Healthcare "City Clinical Hospital of n.a. V.M.Buyanova" "
  • State budget healthcare institution of Novosibirsk region "City clinical hospital #2"
  • Hospital Universitario Cruces
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario Reina Sofía. Hospital Provincial
  • "Hospital Universtiario Donostia "
  • Hospital General Universitario Gregorio Marañon
  • "Hospital Universitario Marqués de Valdecilla "
  • Hospital Universitario de Balme
  • Hospital Universitari Sant Joan de Reus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ridinilazole

vancomycin

Arm Description

ridinilazole 200mg bid

vancomycin 125 mg qid

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Response
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
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
defined as Clinical Response and no recurrence of CDI through 60 days post EOT
Sustained Clinical Response Over 90 Days
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.
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.
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).
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.

Full Information

First Posted
June 11, 2018
Last Updated
March 1, 2023
Sponsor
Summit Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03595553
Brief Title
Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
Acronym
Ri-CoDIFy 1
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
November 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Summit Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridioides Difficile Infection
Keywords
Clostridioides difficile, Clostridium difficile, C. difficile, C. diff

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
759 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ridinilazole
Arm Type
Experimental
Arm Description
ridinilazole 200mg bid
Arm Title
vancomycin
Arm Type
Active Comparator
Arm Description
vancomycin 125 mg qid
Intervention Type
Drug
Intervention Name(s)
Ridinilazole
Other Intervention Name(s)
2,2'-di(pyridin-4-yl)-1H,1'H-5,5'-bi(benzimidazole), 2,2'-bis(4-pyridyl)-3H,3'H-5,5'-bibenzimidazole, 2-pyridin-4-yl-6-(2-pyridin-4-yl-3H-benzimidaz
Intervention Description
ridinilazole (200 mg bid)
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
vancomycin (125 mg qid)
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Day 40
Secondary Outcome Measure Information:
Title
Clinical Response
Description
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.
Time Frame
Day 12
Title
Clinical Cure
Description
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).
Time Frame
Day 12
Title
Sustained Clinical Response Over 60 Days
Description
defined as Clinical Response and no recurrence of CDI through 60 days post EOT
Time Frame
Day 70
Title
Sustained Clinical Response Over 90 Days
Description
defined as Clinical Response and no recurrence of CDI through 90 days post EOT
Time Frame
Day 100
Title
Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT.
Description
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.
Time Frame
Day 10
Title
Percentage of Change of α-diversity (Shannon Index) of the Microbiota in Stool Samples From Baseline to EOT.
Description
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
Time Frame
Day 10
Title
Measure of β-diversity of the Gut Microbiota Between Baseline and EOT Stool Samples (Bray-Curtis Index/Dissimilarity).
Description
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.
Time Frame
Day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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). Exclusion Criteria 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; with any other condition that, in the Investigator's judgment, would make the patient unsuitable for inclusion in the study. 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 who are unwilling or unable to comply with protocol requirements, e.g. complete the full course of study treatment per schedule, attend study visits, report diarrhea/suspected recurrence, provide stool samples, ingest capsules/tablets or blood draws.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Styles, MD
Organizational Affiliation
Summit Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
GI Alliance - Arizona Digestive Health - Sun City
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc
City
Redding
State/Province
California
ZIP/Postal Code
96601
Country
United States
Facility Name
University Of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Midway Immunology and Research Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Alliance Medical Research LLC
City
Lighthouse Point
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
San Marcus Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Phoenix Medical Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Gasteroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
31402
Country
United States
Facility Name
HeuerMD Research Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Pines Care Research Center Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Professional Health Care of Pinellas
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Bardmoor Gastroenterology
City
Seminole
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Florida Medical Clinic P.A.
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Infectious Disease Specialists of Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30333
Country
United States
Facility Name
Grand Teton Research Group PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
GI Alliance - Illinois Gastro Group - Glenview
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
UnityPoint Health Peoria/Proctor
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
St. Vincent Hospital
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608-1216
Country
United States
Facility Name
Harper Hospital Department of Pharmacy Services
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-2020
Country
United States
Facility Name
Detroit Receiving Hospital Department of Pharmacy Services
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Aa Mrc Llc
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504-4730
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073-6712
Country
United States
Facility Name
Revival Research Institute, LLC.
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Mercury Street Medical Group PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
AB Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
James J. Peters VAMC
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
New York Presbyterian Hospital Weill Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
ECU Adult Specialty Care
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
St. Vincent Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Monument Health Clinical Research
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Chattanooga Research and Medicine CHARM
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404-3230
Country
United States
Facility Name
GI Alliance - Texas Digestive Disease Consultants - Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
GI Alliance - Texas Digestive Disease Consultants - Cedar Park
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
DM Clinical Research (Conroe Regional Hospital)
City
Conroe
State/Province
Texas
ZIP/Postal Code
77304
Country
United States
Facility Name
FMC Science
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
GI Alliance - Texas Digestive Disease Consultants - San Marcos
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
GI Alliance - Texas Digestive Disease Consultants - Webster
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Infectious Diseases Associates of Central VA
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Centro Médico Talar
City
El Talar
State/Province
Buenos Aires
ZIP/Postal Code
1608
Country
Argentina
Facility Name
Instituto Medico Platense
City
Buenos Aires
ZIP/Postal Code
BI900AVG
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Hospital Ramos Mejía
City
Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Hospital Privado Centro Medico Cordoba
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Instituto Medico ALAS
City
Salta
ZIP/Postal Code
CP4400
Country
Argentina
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Sunshine Coast University Hospital
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Mater Misericordiae
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Monash Medical Center
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Unidade de Pesquisa - NCS - Hospital Felício Rocho
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110-936
Country
Brazil
Facility Name
Hospital Vera Cruz
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30140-030
Country
Brazil
Facility Name
Santa Casa De Misericordia De Belo Horizonte
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150221
Country
Brazil
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020090
Country
Brazil
Facility Name
Hospital das Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90160-092
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz
City
Sao Paulo
ZIP/Postal Code
01327-001
Country
Brazil
Facility Name
MHAT "Sv.Ivan Rilski-2003"OOD
City
Dupnitsa
State/Province
Kyustendil
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
"MHAT - Blagoevgrad, EOOD Department of Gastroenterology"
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
DCC1-Sliven Ltd.
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
DCC Alexandrovska
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Medical center - Izgrev
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Foothills Medical Centre, South Tower
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Moncton Hospital/Horizon Health Network
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Lakeridge Health
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 1R9
Country
Canada
Facility Name
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec- ULaval
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Recherche Médicale St-Jérôme Inc
City
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
General Hospital of Athens ''Evangelismos'
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
General Hospital of Athens ''Alexandra''
City
Athens
ZIP/Postal Code
115-28
Country
Greece
Facility Name
"Pathophysiology Department Athens University Medical School"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
" ATTIKON University Hospital"
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
"'Hygeia'' Hospital 2nd Department of Medicine and Infectious Diseases"
City
Athens
ZIP/Postal Code
15121 Marousi
Country
Greece
Facility Name
University Hospital of Heraklion
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Facility Name
University Hospital of Patras
City
Patras
ZIP/Postal Code
265 04
Country
Greece
Facility Name
''Tzaneio'' General Hospital of Piraeus
City
Piraeus
ZIP/Postal Code
185 -36
Country
Greece
Facility Name
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház, Infektológia-Hepatológia Osztály
City
Gyula
State/Province
Békés
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Pest Megyei Flór Ferenc Kórház, V. Belgyógyászat
City
Kistarcsa
State/Province
Pest Megye
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Dr. Kenessey Albert Kórház Rendelőintézet, Tüdőgyógyászati Aktív Osztály
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
"Dél-Pesti Centrumkórház-OHII Szent László Kórház Infektológiai Osztály "
City
Budapest
ZIP/Postal Code
H-1097
Country
Hungary
Facility Name
Országos Korányi Pulmonológiai Intézet, Központi Intenzív osztály
City
Budapest
ZIP/Postal Code
H-1122
Country
Hungary
Facility Name
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház IV. Belgyógyászat - 2. Gasztroenterológia
City
Békéscsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
CRU Hungary Kft BAZ Megyei Kórház és Egyetemi Oktatókórház, Szent Ferenc Tagkórház
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
"Pécsi Tudományegyetem I. sz. Belgyógyászat i Klinika, Infektológiai tanszék"
City
Pécs
ZIP/Postal Code
H-7623
Country
Hungary
Facility Name
Pécsi Tudományegyetem Klinikai Központi Gyógyszertár
City
Pécs
ZIP/Postal Code
H-7624
Country
Hungary
Facility Name
Csongrad County Dr. Bugyi Istvan Hospital, Dept. Of Internal Medicine
City
Szentes
ZIP/Postal Code
H-6600
Country
Hungary
Facility Name
Javorszy Odon Hospital
City
Vác
ZIP/Postal Code
2600
Country
Hungary
Facility Name
Hallym University Chuncheon Sacred Heart Hospital
City
Chuncheon
State/Province
Gangwon-do
ZIP/Postal Code
24253
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Ilsan-dong
State/Province
Gangwondo
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Ansan-si
State/Province
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri-Si
State/Province
Gyeonggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospital
City
Ansan
State/Province
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Anyang-si
State/Province
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Seoul
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
State/Province
Seoul
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Irwon-dong
State/Province
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
State/Province
Yeongnam
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Inje University Seoul Paik Hospital
City
Junggu
ZIP/Postal Code
04551
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
05355
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Soeul
ZIP/Postal Code
08307
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Soeul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Waitemata District Health Board WDHB North Shore Hospital
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
0740
Country
New Zealand
Facility Name
Taranaki District Health Board TDHB - Taranaki Base Hospital
City
New Plymouth
State/Province
Taranki
ZIP/Postal Code
4310
Country
New Zealand
Facility Name
Waikato District Health Board Waikato Hospital
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Gabinet Lekarski Bartosz Korczowski
City
Rzeszów
State/Province
Podkarpackie
ZIP/Postal Code
35-302
Country
Poland
Facility Name
SP ZOZ w Bochni Szpital Powiatowy im. B. Marty Wieckiej
City
Bochnia
ZIP/Postal Code
32-700
Country
Poland
Facility Name
Szpital Bocheński SP ZOZ w Bochni
City
Bochnia
ZIP/Postal Code
32-700
Country
Poland
Facility Name
Klinika Chorób Zakaźnych i Hepatologii Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
Facility Name
Szpital Specjalistyczny w Chorzowie
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Szpital Zakonu Bonifratrów
City
Katowice
ZIP/Postal Code
40-211
Country
Poland
Facility Name
Specjalistyczne Gabinety Sp z o.o.
City
Krakow
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Korczowski Bartosz Gabinet
City
Rzeszow
ZIP/Postal Code
35-302
Country
Poland
Facility Name
ENDOSKOPIA Sp. z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA Klinika Chorób Wewnętrznych i Gastroenterologii
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Klinika Chorób Wewnętrznych i Gastroenterologii z Pododdziałem Leczenia Nieswoistych Chorób Zapalnych Jelit Centralny Szpital Kliniczny MSWiA
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego we Wrocławiu; I Oddział Chorób Zakaźnych
City
Wroclaw
ZIP/Postal Code
51-149
Country
Poland
Facility Name
SUUMC-Boli infectioase
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"
City
Bucuresti
ZIP/Postal Code
030303
Country
Romania
Facility Name
S.C. Sana Monitoring Srl
City
Bucuresti
ZIP/Postal Code
11025
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase si Tropicale
City
Bucuresti
ZIP/Postal Code
30303
Country
Romania
Facility Name
Spitalul Minicipal Caracal
City
Caracal
ZIP/Postal Code
235200
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase Constanta
City
Constanta
ZIP/Postal Code
900709
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase- Sfanta Parascheva
City
Iasi
ZIP/Postal Code
700722
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase
City
Iaşi
ZIP/Postal Code
700722
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Timisoara
City
Timișoara
ZIP/Postal Code
300723
Country
Romania
Facility Name
" State Budgetary Institution of Healthcare "City Clinical Hospital of n.a. V.M.Buyanova" "
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
Facility Name
State budget healthcare institution of Novosibirsk region "City clinical hospital #2"
City
Novosibirsk
ZIP/Postal Code
630051
Country
Russian Federation
Facility Name
Hospital Universitario Cruces
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
8041
Country
Spain
Facility Name
Hospital Universitario Reina Sofía. Hospital Provincial
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
"Hospital Universtiario Donostia "
City
Donostia
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
"Hospital Universitario Marqués de Valdecilla "
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario de Balme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Universitari Sant Joan de Reus
City
Tarragona
ZIP/Postal Code
43204
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30767587
Citation
Carlson 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.
Results Reference
derived
Links:
URL
https://www.summittxinc.com/app/uploads/2021/07/ECCMID-2021-Summit-Therapeutics-Ridinilazole-Metagenomics-Gut-Microbiota.pdf
Description
Metagenomic Analysis of the Differential Impact of Ridinilazole and Vancomycin on the Gut Microbiota in a Phase 2 Study

Learn more about this trial

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

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