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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03595566
Other study ID # SMT19969/C005
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 28, 2019
Est. completion date November 19, 2021

Study information

Verified date October 2022
Source Summit Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 404
Est. completion date November 19, 2021
Est. primary completion date November 19, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ridinilazole
ridinilazole 200mg bid
vancomycin
vancomycin 125mg qid

Locations

Country Name City State
Belarus Gomel Regional Clinical Hospital Gomel
Belarus Grodno City Clinical Hospital of Emergency Care Grodno
Belarus City Clinical Hospital of Infectious Diseases Minsk
Belarus Vitebsk regional clinical infectious diseases hospital Vitebsk
Belgium Cliniques Universitaires Saint-Luc, UCL Bruxelles
Belgium Hopital Erasme Bruxelles
Belgium AZ Maria Middelares Gent
Belgium Az St. Lucas Gent
Belgium CHU UCL Namur, Intensive Care Unit Yvoir
Canada University of Alberta, Division of Gastroenterology Edmonton Alberta
Canada St. Josephs Healthcare Hamilton Ontario
Canada Jewish General Hospital Montreal Quebec
Canada Michael Garron Hospital Toronto Ontario
Canada Diamond Health Care Center Vancouver British Columbia
Canada Vancouver General Hospital Vancouver British Columbia
Canada Vancouver Island Health Authority, Research and Capacity Building Victoria British Columbia
Chile Clínica Alemana de Santiago Santiago
Chile Clínica Las Condes Santiago
Czechia Fakultni nemocnice Brno, Klinika infekcnich chorob Brno
Czechia Fakultni nemocnice Hradec Kralove, Klinika infekcnich nemoci Hradec Králové
Czechia Nemocnice Kyjov, Infekcni oddeleni Kyjov
Czechia Krajska nemocnice Liberec Liberec
Estonia Ida-Viru Central Hospital Kohtla-Järve Ida-Viru
Estonia North Estonia Medical Centre Tallinn Harju
France Centre Hospitalier Universitaire Grenoble Alpes Grenoble
France CHD Vendée La Roche-sur-Yon
France Unité de maladies infectieuses - RDJ Ouest - Hôpital Huriez Lille Cedex
France CIC - CHU de Limoges Limoges
France Groupe Hospitalier Bretagne Sud Hopital du Scorff Lorient
France Hopital Bichat - Claude-Bernard Paris
France Hopital Lariboisiere Paris
France Hôpital Saint Antoine Paris
France Hopital Saint Louis Paris
France CH Intercommunal de Cornouaille (CHIC) QUIMPER / MIIS Quimper
Georgia JSC Evex medical corporation Batumi Adjara
Georgia JSC"Infectious Diseases, Aids and Clinical Immunology Research Center" Tbilisi
Georgia LLC"Aversi Clinic" Tbilisi
Georgia LTD "Acad. G. Chapidze Emergency Cardiology Center" Tbilisi
Georgia LTD "Israeli-Georgian Medical research Clinic Helsicore" Tbilisi
Germany Vivantes Klinikum Spandau Berlin
Germany Universitätsklinikum Essen Essen NRW
Germany Universitätsklinikum Köln Köln NRW
Germany Klinikum St. Georg - Klinik für Infektiologie, Tropenmedizin, Nephrologie unfd Rheumatologie Leipzig
Germany Stahl Marburg Hessen
Germany Universitätsklinikum Marburg Marburg
Germany Universitätsmedizin Rostock Rostock
Germany Uni. Klinik Tübingen Innere Medizin I Hepatologische Therapie- und Studienambulanz Tübingen
Germany Kliniken Nordoberpfalz AG, Klinikum Weiden Weiden
Israel Barzilai Medical Center Ashkelon Southern
Israel Infectious Diseases & Infection Control Unit Hadera
Israel Bnai Zion Medical Center Haifa
Israel Rambam Health Care Campus, Internal ward A Haifa
Israel Hadassah-Hebrew University Jerusalem
Israel Meir Medical Center, Infection Diseases Unit Kfar-Sava Central
Israel Rabin Medical Center Petah-Tikva Central
Israel Tel Hashomer Medical Center Ramat Gan
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Latvia Daugavpils Regional Hospital Daugavpils
Latvia Pauls Stradins Clinical University Hospital Riga
Latvia Vidzemes Hospital Valmiera
Lithuania Respublikine Siauliu ligonine Šiauliai
Lithuania Hospital of Lithuanian University of Health Sciences Kaunas
Lithuania Hospital of Lithuanian University of Health Sciences Kauno klinikos Kaunas
Lithuania Kauno klinikine ligonine Kaunas
Lithuania Klaipedos universitetine ligonine Klaipeda
Lithuania Inlita, Santara KTC Vilnius
Mexico Hospital Civil "Fray Antonio Alcalde Guadalajara Jalisco
Mexico Nuevo Hospital Civil de Guadalajara Guadalajara Jalisco
Mexico Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey Nuevo Leon
Mexico Hospital Universitario Dr. José Eleuterio González Monterrey Nuevo Leon
Mexico Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Tlalpan Mexico City
Peru Hospital Nacional Alberto Sabogal Sologuren Callao
Peru Hospital Nacional Edgardo Rebagliati Martins Jesus Maria Lima
Peru Hospital Nacional 2 de Mayo Lima
Romania Spitalul Universitar de Urgenta Bucuresti Bucharest
Romania Fundatia "Dr. Victor Babes" Bucuresti
Romania Institutul National de Boli Infectioase "Prof. Dr. Matei Bals" Bucuresti
Romania Institutul Regional de Gastroenterologie si Hepatologie Cluj-Napoca
Romania Spitalul Clinic de Boli Infectioase Cluj-Napoca Cluj-Napoca
Romania Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Craiova Dolj
Spain Hospital Universitari Germans Trias i Pujol Badalona
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Universitario Virgen de las Nieves Granada
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Majadahonda
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Universitari Mutua de Terrassa Terrassa
Spain Hospital Universitario Alvaro Cunqeiro Vigo
United States PharmaTex Research LLC Amarillo Texas
United States Anne Arundel Medical Center Annapolis Maryland
United States Summit Clinical Research Athens Georgia
United States Emory University School of Medicine Atlanta Georgia
United States St. David's Healthcare Office of Research Austin Texas
United States Tufts Medical Center Boston Massachusetts
United States Clinical Research of Brandon LLC Brandon Florida
United States Montefiore Medical Center Bronx New York
United States University of Chicago Chicago Illinois
United States The Ohio State Wexner Medical Center Columbus Ohio
United States Wright State University and Premier Health Clinical Trials Research Alliance Dayton Ohio
United States Henry Ford Health System Detroit Michigan
United States Moonshine Research Center Inc Doral Florida
United States Horizon Research Group of Opelousas, LLC Eunice Louisiana
United States MediSphere Medical Research Center, LLC Evansville Indiana
United States DHAT Research Institute Garland Texas
United States Hartford Hospital Hartford Connecticut
United States University of Houston Houston Texas
United States University Texas MD Anderson Cancer Center Houston Texas
United States Snake River Research PLLC Idaho Falls Idaho
United States Western Michigan University Homer Stryker M.D. Kalamazoo Michigan
United States Vidant Multispecialty Clinic - Kinston Kinston North Carolina
United States Vidant Multispecialty Clinic - Kinston, Attn. Research Department Kinston North Carolina
United States EvergreenHealth Medical Center Kirkland Washington
United States Multi-Specialty Research Associates Inc. Lake City Florida
United States Florida Research Institute Lakewood Ranch Florida
United States Sierra Clinical Research Las Vegas Nevada
United States Emeritas Research Group Leesburg Virginia
United States University of CA Los Angeles Los Angeles California
United States Gastrointestinal Specialists Of Georgia Marietta Georgia
United States Advanced Medical Research Institute Miami Florida
United States Coral Research Clinic Corp Miami Florida
United States Jackson Memorial Hospital Miami Florida
United States L&C Professional Medical Research Institute Miami Florida
United States Mount Sinai New York New York
United States Arkansas Gastroenterology North Little Rock Arkansas
United States DiGiovanna Institute For Medical Education North Massapequa New York
United States Sarkis Clinical Trials Ocala Florida
United States Advanced Medical Research Center Port Orange Florida
United States Mayo Clinic Rochester Minnesota
United States Washington University School of Medicine Saint Louis Missouri
United States Guthrie Clinic - Sayre Sayre Pennsylvania
United States Louisiana Res Center LLC Shreveport Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Summit Therapeutics

Countries where clinical trial is conducted

United States,  Belarus,  Belgium,  Canada,  Chile,  Czechia,  Estonia,  France,  Georgia,  Germany,  Israel,  Latvia,  Lithuania,  Mexico,  Peru,  Romania,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sustained Clinical Response (SCR) defined as Clinical Response and no recurrence of CDI through 30 days post End of Treatment (EOT). Day 40
Secondary 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.
Day 12
Secondary 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). Day 12
Secondary Sustained Clinical Response over 60 days defined as Clinical Response and no recurrence of CDI through 60 days post EOT Day 70
Secondary Sustained Clinical Response over 90 days defined as Clinical Response and no recurrence of CDI through 90 days post EOT Day 100
Secondary Change from baseline to EOT of the relative abundance of the 3 main bile acid groups (conjugated primary, primary and secondary bile acids) Day 10
Secondary Change from baseline to EOT of the microbiota a-diversity (Shannon) index in stool samples Day 10
Secondary Change from baseline to EOT of the gut microbiota ß-diversity (Bray-Curtis) index in stool samples Day 10
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