RecruitingNCT04801862

Natural History of Clostridioides Difficile Infection

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


Sponsor

Hospital Universitario de Valme

Enrollment

750 participants

Start Date

Jan 1, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with clostridium difficile infection, health care associated infection, and other related conditions. The study is currently recruiting participants at 15 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(15)

Hospital Universitario San Juan

Alicante, Alicante, Spain

Hospital Vega Baja

Orihuela, Alicante, Spain

Hospital Marina Baixa

Villajoyosa, Alicante, Spain

Hospital Universitario de Puerto Real

Puerto Real, Cadiz, Spain

Hospital Universitario San Cecilio

Granada, Granada, Spain

Hospital Juan Ramón Jiménez

Huelva, Huelva, Spain

Hospital Regional Universitario de Málaga

Málaga, Málaga, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Consorcio Hospital General de Valencia

Valencia, Valencia, Spain

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Hospital Politécnico Universitario La Fe de Valencia

Valencia, Valencia, Spain

Hospital General Universitario de Alicante

Alicante, Spain

Hospital Universitario Reina Sofía

Córdoba, Spain

Hospital Universitario de Valme

Seville, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

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NCT04801862


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