Investigating factors related to Clostridioides difficile infection recurrence
Clinical, Microbiological and Genetic Factors Associated With Recurrence of Clostridioides Difficile Infection and Development of a Predictive Tool for Recurrence
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 |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario de Valme Academic / other |
| Locations | 15 sites (Orihuela, Alicante and 14 other locations) |
| Trial ID | NCT04801862 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years who have been newly diagnosed with Clostridioides difficile infection.
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.
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 performed: While studies on CDI have been conducted, this specific approach focusing on host factors and predictive tools is relatively novel.
Eligibility criteria
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 this trial is running
Orihuela, Alicante and 14 other locations
- 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 General Universitario de Alicante — Alicante, Spain (Recruiting)
- Hospital Universitario San Juan — Alicante, Spain (Recruiting)
- Hospital Universitario Reina Sofía — Córdoba, Spain (Terminated)
- Hospital Universitario San Cecilio — Granada, Spain (Recruiting)
- Hospital Juan Ramón Jiménez — Huelva, Spain (Recruiting)
- Hospital Regional Universitario de Málaga — Málaga, Spain (Withdrawn)
- Hospital Universitario Virgen de la Victoria — Málaga, Spain (Recruiting)
- Hospital Universitario de Valme — Sevilla, Spain (Recruiting)
- Hospital Universitario Virgen Macarena — Sevilla, Spain (Recruiting)
- Consorcio Hospital General de Valencia — Valencia, Spain (Recruiting)
- Hospital Clínico Universitario de Valencia — Valencia, Spain (Recruiting)
- Hospital Politécnico Universitario La Fe de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Nicolás Merchante, MD; PhD
- Email: nicolas.merchante.sspa@juntadeandalucia.es
- Phone: 955015895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.