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Clinical trialNCT03595553CompletedPhase 3Interventional

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

SponsorSummit TherapeuticsEnrollment759Clostridioides Difficile Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

149 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina
  • Centro Médico Talar

    El Talar, Buenos Aires, Argentina

  • Hospital Italiano de Buenos Aires

    Buenos Aires, Argentina

  • Hospital Ramos Mejía

    Buenos Aires, Argentina

  • Instituto Medico Platense

    Buenos Aires, Argentina

  • Hospital Privado Centro Medico Cordoba

    Córdoba, Argentina

  • Instituto Medico Alas

    Salta, Argentina

Australia
  • Westmead Hospital

    Westmead, New South Wales, Australia

  • Sunshine Coast University Hospital

    Birtinya, Queensland, Australia

  • Mater Misericordiae

    South Brisbane, Queensland, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, Australia

  • Monash Medical Center

    Clayton, Victoria, Australia

  • Fiona Stanley Hospital

    Murdoch, Western Australia, Australia

Brazil
  • Hospital Vera Cruz

    Belo Horizonte, Minas Gerais, Brazil

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, Minas Gerais, Brazil

  • Unidade de Pesquisa - Ncs - Hospital Felício Rocho

    Belo Horizonte, Minas Gerais, Brazil

  • Hospital Ernesto Dornelles

    Porto Alegre, Rio Grande do Sul, Brazil

  • Hospital Das Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, Brazil

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, Brazil

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    São José do Rio Preto, São Paulo, Brazil

  • Hospital Alemao Oswaldo Cruz

    São Paulo, Brazil

Bulgaria
  • Mhat "sv.Ivan Rilski-2003"ood

    Dupnitsa, Kyustendil, Bulgaria

  • "mhat - Blagoevgrad, Eood Department of Gastroenterology"

    Blagoevgrad, Bulgaria

  • Dcc1-Sliven Ltd.

    Sliven, Bulgaria

  • Dcc Alexandrovska

    Sofia, Bulgaria

  • Medical Center - Izgrev

    Sofia, Bulgaria

Canada
  • Foothills Medical Centre, South Tower

    Calgary, Alberta, Canada

  • Moncton Hospital/horizon Health Network

    Moncton, New Brunswick, Canada

  • Lakeridge Health

    Oshawa, Ontario, Canada

  • Centre Hospitalier de L'Universite de Montreal

    Montreal, Quebec, Canada

  • Centre Integre Universitaire de Sante Et de Services Sociaux de la Mauricie-Et-Du-Centre-Du-Quebec

    Trois-Rivières, Quebec, Canada

  • Institut Universitaire de Cardiologie Et de Pneumologie de Québec- Ulaval

    Québec, Canada

  • Recherche Médicale St-Jérôme Inc

    Québec, Canada

Greece
  • " Attikon University Hospital"

    Athens, Greece

  • "'Hygeia'' Hospital 2nd Department of Medicine and Infectious Diseases"

    Athens, Greece

  • "pathophysiology Department Athens University Medical School"

    Athens, Greece

  • General Hospital of Athens ''Alexandra''

    Athens, Greece

  • General Hospital of Athens ''Evangelismos'

    Athens, Greece

  • University Hospital of Heraklion

    Heraklion, Greece

  • ''Tzaneio'' General Hospital of Piraeus

    Piraeus, Greece

  • University Hospital of Patras

    Pátrai, Greece

109 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

RidinilazoleVancomycin →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Jan 2019
Primary completion
17 Nov 2021
Completion
17 Nov 2021
Last update posted
3 Mar 2023
Registered enrollment
759
Registry id
NCT03595553
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.