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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
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04801862
Enrollment
750
Registered
2021-03-17
Start date
2021-01-01
Completion date
2029-12-31
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Infection, Health Care Associated Infection, Nosocomial Infection

Keywords

Clostridioides difficile, Clostridium difficile, Nosocomial diarrhea, Health care associated infection, Nosocomial infection, Antimicrobial stewardship

Brief 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.

Interventions

None listed

Sponsors

Hospital Universitario de Valme
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age older than 18 years * New episode of Clostridioides difficile infection, based on IDSA criteria.

Exclusion criteria

\- None

Design outcomes

Primary

MeasureTime frameDescription
CDI recurrenceFirst 8 weeks after end of therapyClostridioides difficile recurrence
CDI reinfectionBetween 8 weeks after end of therapy and before 24 weeksNew episode of Clostridioides difficile infection

Secondary

MeasureTime frameDescription
Readmission due to CDI infectionDuring 24 weeks after the end of therapyNew hospitalization related to new Clostridioides difficile infection episode

Countries

Spain

Contacts

CONTACTNicolás Merchante, MD; PhD
nicolas.merchante.sspa@juntadeandalucia.es955015895
CONTACTMiguel Rodríguez Fernández
migrodfer92@gmail.com955015895

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026