Investigating factors related to Clostridioides difficile infection recurrence
Official title: Clinical, Microbiological and Genetic Factors Associated With Recurrence of Clostridioides Difficile Infection and Development of a Predictive Tool for Recurrence
Run by Hospital Universitario de Valme · NCT04801862 · Data updated 2026-11-12
This study is trying to find out how certain body factors, like gut bacteria and genetics, affect the chances of Clostridioides difficile infection coming back in adults who have already been diagnosed with it.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 750 (estimated) |
| Sponsor | Hospital Universitario de Valme Academic / other |
| Locations | 15 sites (Alicante, Alicante and 14 other locations) |
| Status | Recruiting |
| Started | January 1, 2021 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT04801862 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years who have been newly diagnosed with Clostridioides difficile infection.
✕Probably not a fit
Patients who do not have a new episode of Clostridioides difficile infection or are under 18 years old may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the relationship between host factors, such as the composition and diversity of intestinal microbiota and genetic determinants, and the risk of recurrence of Clostridioides difficile infection (CDI). It will involve a multicenter prospective cohort design, enrolling patients over 18 years diagnosed with CDI according to IDSA criteria. Participants will undergo follow-up through a stewardship program designed to enhance CDI management, including early detection of recurrence. Blood and stool samples will be collected for genetic testing and microbiome analysis to identify predictors of CDI recurrence.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for predicting and managing recurrent CDI, enhancing patient outcomes.
How similar studies have gone: While studies on CDI have been conducted, this specific approach focusing on host factors and predictive tools is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age older than 18 years * New episode of Clostridioides difficile infection, based on IDSA criteria. Exclusion Criteria: \- None
Where it's running
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Hospital Universitario San Juan
Alicante, Alicante, Spain Recruiting -
Hospital Vega Baja
Orihuela, Alicante, Spain Recruiting -
Hospital Marina Baixa
Villajoyosa, Alicante, Spain Recruiting -
Hospital Universitario San Cecilio
Granada, Granada, Spain Recruiting -
Hospital Juan Ramón Jiménez
Huelva, Huelva, Spain Recruiting -
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, Spain Recruiting
Show 9 more locations
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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 de Valme
Seville, Spain Recruiting -
Hospital Universitario Virgen Macarena
Seville, Spain Recruiting -
Hospital Universitario de Puerto Real
Puerto Real, Cadiz, Spain Terminated -
Hospital Regional Universitario de Málaga
Málaga, Málaga, Spain Withdrawn -
Hospital Universitario Reina Sofía
Córdoba, Spain Terminated
Study contacts
- Study coordinator: Nicolás Merchante, MD; PhD
- Email: nicolas.merchante.sspa@juntadeandalucia.es
- Phone: 955015895
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.