Natural History of Clostridioides Difficile Infection

Study Overview
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Brief Summary
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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.

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

Conditions
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Clostridium Difficile Infection, Health Care Associated Infection, Nosocomial Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age older than 18 years New episode of Clostridioides difficile infection, based on IDSA criteria. Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients diagnosed of C.difficile infection<br>Open cohort of consecutive patients diagnosed of Clostridioides difficile infection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridioides difficile, Clostridium difficile, Nosocomial diarrhea, Health care associated infection, Nosocomial infection, Antimicrobial stewardship