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To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection (Ri-CoDIFy 2)

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 Clostridium difficile, Clostridioides 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

  • Arkansas Gastroenterology
  • University of CA Los Angeles
  • Hartford Hospital
  • Clinical Research of Brandon LLC
  • Moonshine Research Center Inc
  • Multi-Specialty Research Associates Inc.
  • Florida Research Institute
  • Jackson Memorial Hospital
  • L&C Professional Medical Research Institute
  • Advanced Medical Research Institute
  • Coral Research Clinic Corp
  • Sarkis Clinical Trials
  • Advanced Medical Research Center
  • Summit Clinical Research
  • Emory University School of Medicine
  • Gastrointestinal Specialists Of Georgia
  • Snake River Research PLLC
  • University of Chicago
  • MediSphere Medical Research Center, LLC
  • Horizon Research Group of Opelousas, LLC
  • Louisiana Res Center LLC
  • Anne Arundel Medical Center
  • Tufts Medical Center
  • Henry Ford Health System
  • Western Michigan University Homer Stryker M.D.
  • Mayo Clinic
  • Washington University School of Medicine
  • Sierra Clinical Research
  • Montefiore Medical Center
  • Mount Sinai
  • DiGiovanna Institute For Medical Education
  • Vidant Multispecialty Clinic - Kinston, Attn. Research Department
  • Vidant Multispecialty Clinic - Kinston
  • The Ohio State Wexner Medical Center
  • Wright State University and Premier Health Clinical Trials Research Alliance
  • Guthrie Clinic - Sayre
  • PharmaTex Research LLC
  • St. David's Healthcare Office of Research
  • DHAT Research Institute
  • University of Houston
  • University Texas MD Anderson Cancer Center
  • Emeritas Research Group
  • EvergreenHealth Medical Center
  • Gomel Regional Clinical Hospital
  • Grodno City Clinical Hospital of Emergency Care
  • City Clinical Hospital of Infectious Diseases
  • Vitebsk regional clinical infectious diseases hospital
  • Hopital Erasme
  • Cliniques Universitaires Saint-Luc, UCL
  • AZ Maria Middelares
  • Az St. Lucas
  • CHU UCL Namur, Intensive Care Unit
  • University of Alberta, Division of Gastroenterology
  • Diamond Health Care Center
  • Vancouver General Hospital
  • Vancouver Island Health Authority, Research and Capacity Building
  • St. Josephs Healthcare
  • Michael Garron Hospital
  • Jewish General Hospital
  • Clínica Las Condes
  • Clínica Alemana de Santiago
  • Fakultni nemocnice Brno, Klinika infekcnich chorob
  • Fakultni nemocnice Hradec Kralove, Klinika infekcnich nemoci
  • Nemocnice Kyjov, Infekcni oddeleni
  • Krajska nemocnice Liberec
  • North Estonia Medical Centre
  • Ida-Viru Central Hospital
  • Unité de maladies infectieuses - RDJ Ouest - Hôpital Huriez
  • Centre Hospitalier Universitaire Grenoble Alpes
  • CHD Vendée
  • CIC - CHU de Limoges
  • Groupe Hospitalier Bretagne Sud Hopital du Scorff
  • Hopital Saint Louis
  • Hôpital Saint Antoine
  • Hopital Bichat - Claude-Bernard
  • Hopital Lariboisiere
  • CH Intercommunal de Cornouaille (CHIC) QUIMPER / MIIS
  • JSC Evex medical corporation
  • LTD "Israeli-Georgian Medical research Clinic Helsicore"
  • LTD "Acad. G. Chapidze Emergency Cardiology Center"
  • JSC"Infectious Diseases, Aids and Clinical Immunology Research Center"
  • LLC"Aversi Clinic"
  • Stahl
  • Universitätsklinikum Essen
  • Universitätsklinikum Köln
  • Vivantes Klinikum Spandau
  • Klinikum St. Georg - Klinik für Infektiologie, Tropenmedizin, Nephrologie unfd Rheumatologie
  • Universitätsklinikum Marburg
  • Universitätsmedizin Rostock
  • Uni. Klinik Tübingen Innere Medizin I Hepatologische Therapie- und Studienambulanz
  • Kliniken Nordoberpfalz AG, Klinikum Weiden
  • Meir Medical Center, Infection Diseases Unit
  • Rabin Medical Center
  • Barzilai Medical Center
  • Infectious Diseases & Infection Control Unit
  • Bnai Zion Medical Center
  • Rambam Health Care Campus, Internal ward A
  • Hadassah-Hebrew University
  • Tel Hashomer Medical Center
  • Tel Aviv Sourasky Medical Center
  • Daugavpils Regional Hospital
  • Pauls Stradins Clinical University Hospital
  • Vidzemes Hospital
  • Kauno klinikine ligonine
  • Hospital of Lithuanian University of Health Sciences Kauno klinikos
  • Hospital of Lithuanian University of Health Sciences
  • Klaipedos universitetine ligonine
  • Inlita, Santara KTC
  • Respublikine Siauliu ligonine
  • Hospital Civil "Fray Antonio Alcalde
  • Nuevo Hospital Civil de Guadalajara
  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Hospital Universitario Dr. José Eleuterio González
  • Hospital Nacional Edgardo Rebagliati Martins
  • Hospital Nacional Alberto Sabogal Sologuren
  • Hospital Nacional 2 de Mayo
  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie
  • Spitalul Universitar de Urgenta Bucuresti
  • Fundatia "Dr. Victor Babes"
  • Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
  • Spitalul Clinic de Boli Infectioase Cluj-Napoca
  • Institutul Regional de Gastroenterologie şi Hepatologie
  • Hospital Universitari Germans Trias i Pujol
  • Hospital del Mar
  • Hospital Clinic de Barcelona
  • Hospital Universitario Virgen de las Nieves
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Universitario Virgen Macarena
  • Hospital Universitari Mutua de Terrassa
  • Hospital Universitario Alvaro Cunqeiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ridinilazole

vancomycin

Arm Description

Outcomes

Primary Outcome Measures

Sustained Clinical Response (SCR) defined as Clinical Response and no recurrence of CDI through 30 days post End of Treatment (EOT).

Secondary Outcome Measures

Clinical Response
defined as less than 3 unformed bowel movements (UBMs) for 2 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
Change from baseline to EOT of the relative abundance of the 3 main bile acid groups (conjugated primary, primary and secondary bile acids)
Change from baseline to EOT of the microbiota α-diversity (Shannon) index in stool samples
Change from baseline to EOT of the gut microbiota β-diversity (Bray-Curtis) index in stool samples

Full Information

First Posted
June 11, 2018
Last Updated
October 11, 2022
Sponsor
Summit Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03595566
Brief Title
To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
Acronym
Ri-CoDIFy 2
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
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
November 19, 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridioides Difficile Infection
Keywords
Clostridium difficile, Clostridioides 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 the same number and appearance of IP in both arms.
Allocation
Randomized
Enrollment
404 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ridinilazole
Arm Type
Experimental
Arm Title
vancomycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ridinilazole
Intervention Description
ridinilazole 200mg bid
Intervention Type
Drug
Intervention Name(s)
vancomycin
Intervention Description
vancomycin 125mg qid
Primary Outcome Measure Information:
Title
Sustained Clinical Response (SCR) defined as Clinical Response and no recurrence of CDI through 30 days post End of Treatment (EOT).
Time Frame
Day 40
Secondary Outcome Measure Information:
Title
Clinical Response
Description
defined as less than 3 unformed bowel movements (UBMs) for 2 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
Change from baseline to EOT of the relative abundance of the 3 main bile acid groups (conjugated primary, primary and secondary bile acids)
Time Frame
Day 10
Title
Change from baseline to EOT of the microbiota α-diversity (Shannon) index in stool samples
Time Frame
Day 10
Title
Change from baseline to EOT of the gut microbiota β-diversity (Bray-Curtis) index in stool samples
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
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
University of CA Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Clinical Research of Brandon LLC
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Moonshine Research Center Inc
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Multi-Specialty Research Associates Inc.
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Florida Research Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
L&C Professional Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Advanced Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Coral Research Clinic Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Sarkis Clinical Trials
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Advanced Medical Research Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Summit Clinical Research
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
Gastrointestinal Specialists Of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Snake River Research PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Horizon Research Group of Opelousas, LLC
City
Eunice
State/Province
Louisiana
ZIP/Postal Code
70535
Country
United States
Facility Name
Louisiana Res Center LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21404
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Western Michigan University Homer Stryker M.D.
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Sierra Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
DiGiovanna Institute For Medical Education
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Vidant Multispecialty Clinic - Kinston, Attn. Research Department
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Vidant Multispecialty Clinic - Kinston
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
The Ohio State Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Wright State University and Premier Health Clinical Trials Research Alliance
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Guthrie Clinic - Sayre
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
PharmaTex Research LLC
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
St. David's Healthcare Office of Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
DHAT Research Institute
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Emeritas Research Group
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
21076
Country
United States
Facility Name
EvergreenHealth Medical Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Gomel Regional Clinical Hospital
City
Gomel
ZIP/Postal Code
246029
Country
Belarus
Facility Name
Grodno City Clinical Hospital of Emergency Care
City
Grodno
ZIP/Postal Code
230027
Country
Belarus
Facility Name
City Clinical Hospital of Infectious Diseases
City
Minsk
ZIP/Postal Code
220002
Country
Belarus
Facility Name
Vitebsk regional clinical infectious diseases hospital
City
Vitebsk
ZIP/Postal Code
210009
Country
Belarus
Facility Name
Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc, UCL
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Az St. Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU UCL Namur, Intensive Care Unit
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
University of Alberta, Division of Gastroenterology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Diamond Health Care Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Vancouver Island Health Authority, Research and Capacity Building
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
St. Josephs Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Michael Garron Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C- 3E7
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Clínica Las Condes
City
Santiago
ZIP/Postal Code
7591047
Country
Chile
Facility Name
Clínica Alemana de Santiago
City
Santiago
ZIP/Postal Code
7650567
Country
Chile
Facility Name
Fakultni nemocnice Brno, Klinika infekcnich chorob
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove, Klinika infekcnich nemoci
City
Hradec Králové
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Nemocnice Kyjov, Infekcni oddeleni
City
Kyjov
ZIP/Postal Code
69701
Country
Czechia
Facility Name
Krajska nemocnice Liberec
City
Liberec
ZIP/Postal Code
460 63
Country
Czechia
Facility Name
North Estonia Medical Centre
City
Tallinn
State/Province
Harju
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Ida-Viru Central Hospital
City
Kohtla-Järve
State/Province
Ida-Viru
ZIP/Postal Code
31025
Country
Estonia
Facility Name
Unité de maladies infectieuses - RDJ Ouest - Hôpital Huriez
City
Lille
State/Province
Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Universitaire Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHD Vendée
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CIC - CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Groupe Hospitalier Bretagne Sud Hopital du Scorff
City
Lorient
ZIP/Postal Code
56322
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Bichat - Claude-Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CH Intercommunal de Cornouaille (CHIC) QUIMPER / MIIS
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
JSC Evex medical corporation
City
Batumi
State/Province
Adjara
ZIP/Postal Code
6010
Country
Georgia
Facility Name
LTD "Israeli-Georgian Medical research Clinic Helsicore"
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LTD "Acad. G. Chapidze Emergency Cardiology Center"
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
JSC"Infectious Diseases, Aids and Clinical Immunology Research Center"
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LLC"Aversi Clinic"
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Stahl
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
NRW
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
State/Province
NRW
ZIP/Postal Code
50937
Country
Germany
Facility Name
Vivantes Klinikum Spandau
City
Berlin
ZIP/Postal Code
13585
Country
Germany
Facility Name
Klinikum St. Georg - Klinik für Infektiologie, Tropenmedizin, Nephrologie unfd Rheumatologie
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
Universitätsklinikum Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Universitätsmedizin Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Uni. Klinik Tübingen Innere Medizin I Hepatologische Therapie- und Studienambulanz
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Kliniken Nordoberpfalz AG, Klinikum Weiden
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Facility Name
Meir Medical Center, Infection Diseases Unit
City
Kfar-Sava
State/Province
Central
ZIP/Postal Code
4428162
Country
Israel
Facility Name
Rabin Medical Center
City
Petah-Tikva
State/Province
Central
ZIP/Postal Code
49100
Country
Israel
Facility Name
Barzilai Medical Center
City
Ashkelon
State/Province
Southern
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Infectious Diseases & Infection Control Unit
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Health Care Campus, Internal ward A
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah-Hebrew University
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Tel Hashomer Medical Center
City
Ramat Gan
ZIP/Postal Code
5266202
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Vidzemes Hospital
City
Valmiera
ZIP/Postal Code
4201
Country
Latvia
Facility Name
Kauno klinikine ligonine
City
Kaunas
ZIP/Postal Code
47144
Country
Lithuania
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno klinikos
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Hospital of Lithuanian University of Health Sciences
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Klaipedos universitetine ligonine
City
Klaipėda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Inlita, Santara KTC
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Facility Name
Respublikine Siauliu ligonine
City
Šiauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
Hospital Civil "Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Nuevo Hospital Civil de Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
Tlalpan
State/Province
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital Universitario Dr. José Eleuterio González
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital Nacional Edgardo Rebagliati Martins
City
Jesus Maria
State/Province
Lima
ZIP/Postal Code
15072
Country
Peru
Facility Name
Hospital Nacional Alberto Sabogal Sologuren
City
Callao
ZIP/Postal Code
7016
Country
Peru
Facility Name
Hospital Nacional 2 de Mayo
City
Lima
ZIP/Postal Code
15003
Country
Peru
Facility Name
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200515
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Fundatia "Dr. Victor Babes"
City
Bucuresti
ZIP/Postal Code
030303
Country
Romania
Facility Name
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
City
Bucuresti
ZIP/Postal Code
21105
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400000
Country
Romania
Facility Name
Institutul Regional de Gastroenterologie şi Hepatologie
City
Cluj-Napoca
ZIP/Postal Code
400158
Country
Romania
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitari Mutua de Terrassa
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Universitario Alvaro Cunqeiro
City
Vigo
ZIP/Postal Code
36312
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://journals.physiology.org/doi/full/10.1152/ajpgi.00046.2020
Description
Ridinilazole, a narrow spectrum antibiotic for treatment of Clostridioides difficile infection, enhances preservation of microbiota-dependent bile acids

Learn more about this trial

To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

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