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 Type
OBSERVATIONAL
Enrollment
750
Hospital Vega Baja
Orihuela, Alicante, Spain
RECRUITINGHospital Marina Baixa
Villajoyosa, Alicante, Spain
RECRUITINGHospital Universitario de Puerto Real
Puerto Real, Cadiz, Spain
TERMINATEDHospital General Universitario de Alicante
Alicante, Spain
RECRUITINGHospital Universitario San Juan
Alicante, Spain
RECRUITINGHospital Universitario Reina Sofía
Córdoba, Spain
TERMINATEDHospital Universitario San Cecilio
Granada, Spain
RECRUITINGHospital Juan Ramón Jiménez
Huelva, Spain
RECRUITINGHospital Regional Universitario de Málaga
Málaga, Spain
WITHDRAWNHospital Universitario Virgen de la Victoria
Málaga, Spain
RECRUITING...and 5 more locations
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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