Natural History of Clostridioides Difficile Infection

March 3, 2024 updated by: Nicolás Merchante, Hospital Universitario de Valme

Clinical, Microbiological and Genetic Factors Associated With Recurrence of Clostridioides Difficile Infection and Development of a Predictive Tool for Recurrence

Aim: To investigate if host factors, such as composition and diversity of intestinal microbiota and/or genetic determinants, are associated with a higher risk of recurrence of Clostridioides difficile infection (CDI). To generate a predictive tool based on epidemiological, clinical, genetic and microbiologic variables aimed to identify patients at a higher risk of CDI recurrence in a context of optimized ICD management. Design: Multicenter prospective cohort study. Patients: Older than 18 years patients with CDI diagnosis, made by IDSA criteria, in the participant centers.

Follow-up: A stewarship program aimed to improve CDI management, including early detection of CDI recurrence, will be implemented in the participant centers. Blood samples for genetic testing and stool samples for intestinal microbiome studies will be collected.

Variables and data analysis: The primary outcome variable will be the emergence of CDI recurrence. Potential independent predictors of recurrence, including genetic and microbiological factors, will be assessed. A predictive tool based on independent predictors of recurrence will be built in a development subpopulation. The performance of the model will be assessed by ROC curves, and sensititvity, especificity, as well as negative and positive predictive values will be calculated, both in the development subpopulation and in a validation subset.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Alicante, Spain
        • Recruiting
        • Hospital General Universitario de Alicante
        • Principal Investigator:
          • Juan Carlos Rodríguez
        • Principal Investigator:
          • Esperanza Merino
        • Sub-Investigator:
          • Maria Paz Ventero
        • Contact:
          • Esperanza Merino
      • Alicante, Spain
        • Recruiting
        • Hospital Universitario San Juan
        • Contact:
          • Francisco Jover
        • Principal Investigator:
          • Francisco Jover
      • Córdoba, Spain
        • Terminated
        • Hospital Universitario Reina Sofia
      • Granada, Spain
        • Recruiting
        • Hospital Universitario San Cecilio
        • Contact:
          • Emilio Guirao
        • Principal Investigator:
          • Emilio Guirao
      • Huelva, Spain
        • Recruiting
        • Hospital Juan Ramón Jimenez
        • Contact:
          • Francisco J. Martínez Marcos
        • Principal Investigator:
          • Francisco J. Martínez Marcos
      • Málaga, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Cristina Gómez Ayerbe
        • Principal Investigator:
          • Cristina Gómez Ayerbe
      • Málaga, Spain
        • Withdrawn
        • Hospital Regional Universitario de Málaga
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario de Valme
        • Contact:
        • Principal Investigator:
          • Nicolás Merchante
        • Sub-Investigator:
          • Marta Trigo Rodríguez
        • Sub-Investigator:
          • Rocío Herrero
        • Sub-Investigator:
          • Miguel Rodríguez Fernández
        • Sub-Investigator:
          • Maria Dolores Valverde-Fredet Ruiz
        • Sub-Investigator:
          • Ana I. Aller García
        • Sub-Investigator:
          • Eva M. León Jiménez
        • Sub-Investigator:
          • Pedro M. Martínez Pérez-Crespo
        • Sub-Investigator:
          • Reinaldo Espíndola Gómez
        • Sub-Investigator:
          • Juan E. Corzo Delgado
        • Sub-Investigator:
          • Joaquín F. Lanz
        • Sub-Investigator:
          • Lucía Valiente de Santis
        • Sub-Investigator:
          • Antonio Fernández Pevida
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Virginia Palomo
        • Principal Investigator:
          • Miguel Nicolás Navarrete
      • Valencia, Spain
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
          • Rosa Oltra
        • Principal Investigator:
          • Rosa Oltra
      • Valencia, Spain
        • Recruiting
        • Consorcio Hospital General de Valencia
        • Contact:
          • Vicente Abril
        • Principal Investigator:
          • Vicente Abril
      • Valencia, Spain
        • Recruiting
        • Hospital Politécnico Universitario La Fe de Valencia
        • Contact:
          • Maria Tasias
        • Principal Investigator:
          • Maria Tasias
    • Alicante
      • Orihuela, Alicante, Spain
        • Recruiting
        • Hospital Vega Baja
        • Contact:
          • María García
        • Principal Investigator:
          • María García
      • Villajoyosa, Alicante, Spain
        • Recruiting
        • Hospital Marina Baixa
        • Contact:
          • Concepción Gil
        • Principal Investigator:
          • Concepción Gil
    • Cadiz
      • Puerto Real, Cadiz, Spain
        • Terminated
        • Hospital Universitario de Puerto Real

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed of Clostridoides difficile infection

Description

Inclusion Criteria:

  • Age older than 18 years
  • New episode of Clostridioides difficile infection, based on IDSA criteria.

Exclusion Criteria:

- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients diagnosed of C.difficile infection
Open cohort of consecutive patients diagnosed of Clostridioides difficile infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDI recurrence
Time Frame: First 8 weeks after end of therapy
Clostridioides difficile recurrence
First 8 weeks after end of therapy
CDI reinfection
Time Frame: Between 8 weeks after end of therapy and before 24 weeks
New episode of Clostridioides difficile infection
Between 8 weeks after end of therapy and before 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission due to CDI infection
Time Frame: During 24 weeks after the end of therapy
New hospitalization related to new Clostridioides difficile infection episode
During 24 weeks after the end of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario de Valme

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 12, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI20/01450

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Clostridium Difficile Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe