NCT04801862 Natural History of Clostridioides Difficile Infection
| NCT ID | NCT04801862 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario de Valme |
| Condition | Clostridium Difficile Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 750 participants in total. It began in 2021-01-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Age older than 18 years * New episode of Clostridioides difficile infection, based on IDSA criteria. Exclusion Criteria: \- None
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04801862 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Clostridium Difficile Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04801862 currently recruiting?
Yes, NCT04801862 is actively recruiting participants. Contact the research team at nicolas.merchante.sspa@juntadeandalucia.es for enrollment information.
Where is the NCT04801862 trial being conducted?
This trial is being conducted at Alicante, Spain, Orihuela, Spain, Villajoyosa, Spain, Puerto Real, Spain and 11 additional locations.
Who is sponsoring the NCT04801862 clinical trial?
NCT04801862 is sponsored by Hospital Universitario de Valme. The trial plans to enroll 750 participants.