NCT04801862

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 750 (estimated)
• Sponsor: Hospital Universitario de Valme · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridium Difficile Infection
• Health Care Associated Infection
• Nosocomial Infection

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2021-03-17
• Last updated: 2024-03-06

Locations

15 sites across 1 country: Spain