Clinical, Microbiological and Genetic Factors Associated With Recurrence of Clostridioides Difficile Infection and Development of a Predictive Tool for Recurrence
| Registry | NCT04801862 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 750 (Estimated) |
| Sponsor | Hospital Universitario de Valme (Other) |
| Conditions | Clostridium Difficile Infection, Health Care Associated Infection, Nosocomial Infection |
| Dates | start 2021-01-01, primary completion 2029-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2021-03-17, last updated 2026-09-17 |
| Locations | 15 sites in Spain |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patients diagnosed of C.difficile infection | Open cohort of consecutive patients diagnosed of Clostridioides difficile infection |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Age older than 18 years * New episode of Clostridioides difficile infection, based on IDSA criteria. Exclusion Criteria: \- None
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Universitario San Juan | Alicante, Alicante | Spain | Recruiting |
| Hospital Vega Baja | Orihuela, Alicante | Spain | Recruiting |
| Hospital Marina Baixa | Villajoyosa, Alicante | Spain | Recruiting |
| Hospital Universitario de Puerto Real | Puerto Real, Cadiz | Spain | Terminated |
| Hospital Universitario San Cecilio | Granada, Granada | Spain | Recruiting |
| Hospital Juan Ramón Jiménez | Huelva, Huelva | Spain | Recruiting |
| Hospital Regional Universitario de Málaga | Málaga, Málaga | Spain | Withdrawn |
| Hospital Universitario Virgen de la Victoria | Málaga, Málaga | Spain | Recruiting |
| Consorcio Hospital General de Valencia | Valencia, Valencia | Spain | Recruiting |
| Hospital Clínico Universitario de Valencia | Valencia, Valencia | Spain | Recruiting |
| Hospital Politécnico Universitario La Fe de Valencia | Valencia, Valencia | Spain | Recruiting |
| Hospital General Universitario de Alicante | Alicante | Spain | Recruiting |
| Hospital Universitario Reina Sofía | Córdoba | Spain | Terminated |
| Hospital Universitario de Valme | Seville | Spain | Recruiting |
| Hospital Universitario Virgen Macarena | Seville | Spain | Recruiting |