An observational study in Clostridium Difficile Infection, Health Care Associated Infection and Nosocomial Infection, sponsored by Hospital Universitario de Valme. Recruiting at 15 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Hospital Universitario de Valme · Observational
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.
251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
This study's planned enrollment of 750 is above the median of 226 across 52 observational studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →Hospital Universitario de Valme is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients diagnosed of Clostridoides difficile infection
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Exclusion Criteria:
- None
Open cohort of consecutive patients diagnosed of Clostridioides difficile infection
CDI recurrence
Clostridioides difficile recurrence
Time frame: First 8 weeks after end of therapy
CDI reinfection
New episode of Clostridioides difficile infection
Time frame: Between 8 weeks after end of therapy and before 24 weeks
Readmission due to CDI infection
New hospitalization related to new Clostridioides difficile infection episode
Time frame: During 24 weeks after the end of therapy
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Plan to share: Undecided
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Hospital Universitario de Valme