NCT04801862

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

3.5 years

First QC Date

March 12, 2021

Last Update Submit

March 3, 2024

Conditions

Clostridium Difficile InfectionHealth Care Associated InfectionNosocomial Infection

Keywords

Clostridioides difficileClostridium difficileNosocomial diarrheaHealth care associated infectionNosocomial infectionAntimicrobial stewardship

Outcome Measures

Primary Outcomes (2)

  • CDI recurrence

    Clostridioides difficile recurrence

    First 8 weeks after end of therapy

  • CDI reinfection

    New episode of Clostridioides difficile infection

    Between 8 weeks after end of therapy and before 24 weeks

Secondary Outcomes (1)

  • Readmission due to CDI infection

    During 24 weeks after the end of therapy

Study Arms (1)

Patients diagnosed of C.difficile infection

Open cohort of consecutive patients diagnosed of Clostridioides difficile infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed of Clostridoides difficile infection

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hospital Vega Baja

Orihuela, Alicante, Spain

RECRUITING

Hospital Marina Baixa

Villajoyosa, Alicante, Spain

RECRUITING

Hospital Universitario de Puerto Real

Puerto Real, Cadiz, Spain

TERMINATED

Hospital General Universitario de Alicante

Alicante, Spain

RECRUITING

Hospital Universitario San Juan

Alicante, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Spain

TERMINATED

Hospital Universitario San Cecilio

Granada, Spain

RECRUITING

Hospital Juan Ramón Jiménez

Huelva, Spain

RECRUITING

Hospital Regional Universitario de Málaga

Málaga, Spain

WITHDRAWN

Hospital Universitario Virgen de la Victoria

Málaga, Spain

RECRUITING

Hospital Universitario de Valme

Seville, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Spain

RECRUITING

Consorcio Hospital General de Valencia

Valencia, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital Politécnico Universitario La Fe de Valencia

Valencia, Spain

RECRUITING

Related Publications (3)

  • Merchante N, Herrero R, Valverde-Fredet MD, Rodriguez-Fernandez M, Pinagorte H, Martinez-Marcos FJ, Gil-Anguita C, Garcia-Lopez M, Tasias Pitarch M, Abril Lopez De Medrano V, Navarrete Lorite MN, Gomez-Ayerbe C, Leon E, Gonzalez-De La Aleja P, Ruiz Castillo A, Aller AI, Rodriguez JC, Ternero Fonseca J, Corzo JE, Naranjo Perez A, Trigo-Rodriguez M, Merino E. Role of previous systemic antibiotic therapy on the probability of recurrence after an initial episode of Clostridioides difficile infection treated with vancomycin. JAC Antimicrob Resist. 2023 Mar 23;5(2):dlad033. doi: 10.1093/jacamr/dlad033. eCollection 2023 Apr.

    PMID: 36968953BACKGROUND

  • Merchante N, Chico P, Marquez-Saavedra E, Riera G, Herrero R, Gonzalez-de-la-Aleja P, Aller AI, Rodriguez JC, Rodriguez-Fernandez M, Ramos JM, Trigo-Rodriguez M, Merino E. Impact of COVID19 pandemic on the incidence of health-care associated Clostridioides difficile infection. Anaerobe. 2022 Jun;75:102579. doi: 10.1016/j.anaerobe.2022.102579. Epub 2022 Apr 30.

    PMID: 35500744BACKGROUND

  • Rodriguez-Fernandez M, Herrero R, Gonzalez-De-La-Aleja P, Valverde-Fredet MD, Ventero MP, Trigo-Rodriguez M, Giner L, Aller-Garcia AI, Pinargote-Celorio H, Espindola-Gomez R, Parra M, Martinez Perez-Crespo P, Ramos-Rincon JM, Fernandez-Pevida A, Lanz-Garcia J, Leon E, Valiente-De-Santis L, Corzo JE, Rodriguez JC, Merino E, Merchante N. Clinical Impact of Implementing a Specific Clinical Pathway for the Management of Clostridioides difficile Infection. Infect Dis Ther. 2025 Nov 7. doi: 10.1007/s40121-025-01261-9. Online ahead of print.

    PMID: 41201562DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for genetic studies and stool samples for microbiological studies

MeSH Terms

Conditions

Clostridium InfectionsCross Infection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Nicolás Merchante, MD; PhD

CONTACT

955015895nicolas.merchante.sspa@juntadeandalucia.es

Miguel Rodríguez Fernández

CONTACT

955015895migrodfer92@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of the UCEIM-HUV Research Group

Study Record Dates

First Submitted

March 12, 2021

First Posted

March 17, 2021

Study Start

January 1, 2021

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

ES(15)