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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients diagnosed of C.difficile infection | Open cohort of consecutive patients diagnosed of Clostridioides difficile infection |
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| Measure | Description | Time Frame |
|---|---|---|
| CDI recurrence | Clostridioides difficile recurrence | First 8 weeks after end of therapy |
| CDI reinfection | New episode of Clostridioides difficile infection | Between 8 weeks after end of therapy and before 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Readmission due to CDI infection | New hospitalization related to new Clostridioides difficile infection episode | During 24 weeks after the end of therapy |
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Inclusion Criteria:
Exclusion Criteria:
- None
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Adult patients diagnosed of Clostridoides difficile infection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolás Merchante, MD; PhD | Contact | 955015895 | nicolas.merchante.sspa@juntadeandalucia.es | |
| Miguel Rodríguez Fernández | Contact | 955015895 | migrodfer92@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vega Baja | Recruiting | Orihuela | Alicante | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36968953 | Background | Merchante N, Herrero R, Valverde-Fredet MD, Rodriguez-Fernandez M, Pinagorte H, Martinez-Marcos FJ, Gil-Anguita C, Garcia-Lopez M, Tasias Pitarch M, Abril Lopez De Medrano V, Navarrete Lorite MN, Gomez-Ayerbe C, Leon E, Gonzalez-De La Aleja P, Ruiz Castillo A, Aller AI, Rodriguez JC, Ternero Fonseca J, Corzo JE, Naranjo Perez A, Trigo-Rodriguez M, Merino E. Role of previous systemic antibiotic therapy on the probability of recurrence after an initial episode of Clostridioides difficile infection treated with vancomycin. JAC Antimicrob Resist. 2023 Mar 23;5(2):dlad033. doi: 10.1093/jacamr/dlad033. eCollection 2023 Apr. | |
| 35500744 |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Blood sample for genetic studies and stool samples for microbiological studies
| Hospital Marina Baixa | Recruiting | Villajoyosa | Alicante | Spain |
|
| Hospital Universitario de Puerto Real | Terminated | Puerto Real | Cadiz | Spain |
| Hospital General Universitario de Alicante | Recruiting | Alicante | Spain |
|
| Hospital Universitario San Juan | Recruiting | Alicante | Spain |
|
| Hospital Universitario Reina Sofía | Terminated | Córdoba | Spain |
| Hospital Universitario San Cecilio | Recruiting | Granada | Spain |
|
| Hospital Juan Ramón Jiménez | Recruiting | Huelva | Spain |
|
| Hospital Regional Universitario de Málaga | Withdrawn | Málaga | Spain |
| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | Spain |
|
| Hospital Universitario de Valme | Recruiting | Seville | Spain |
|
| Hospital Universitario Virgen Macarena | Recruiting | Seville | Spain |
|
| Consorcio Hospital General de Valencia | Recruiting | Valencia | Spain |
|
| Hospital Clínico Universitario de Valencia | Recruiting | Valencia | Spain |
|
| Hospital Politécnico Universitario La Fe de Valencia | Recruiting | Valencia | Spain |
|
| Background |
| Merchante N, Chico P, Marquez-Saavedra E, Riera G, Herrero R, Gonzalez-de-la-Aleja P, Aller AI, Rodriguez JC, Rodriguez-Fernandez M, Ramos JM, Trigo-Rodriguez M, Merino E. Impact of COVID19 pandemic on the incidence of health-care associated Clostridioides difficile infection. Anaerobe. 2022 Jun;75:102579. doi: 10.1016/j.anaerobe.2022.102579. Epub 2022 Apr 30. |
| 41750443 | Derived | Ventero MP, Valverde-Fredet MD, Merino E, Herrero R, Germak IT, Rodriguez-Fernandez M, Ramos-Rincon JM, Garcia M, Delgado-Sanchez E, Navarrete-Lorite MN, Gil C, Tasias M, Caston JJ, Vinuesa-Garcia D, Gomez-Ayerbe C, Marcos FJM, Merchante N, Rodriguez JC. Antimicrobial Susceptibility of Clostridioides difficile in Spain: Multicenter Retrospective Cohort Study. Antibiotics (Basel). 2026 Feb 2;15(2):145. doi: 10.3390/antibiotics15020145. |
| 41201562 | Derived | Rodriguez-Fernandez M, Herrero R, Gonzalez-De-La-Aleja P, Valverde-Fredet MD, Ventero MP, Trigo-Rodriguez M, Giner L, Aller-Garcia AI, Pinargote-Celorio H, Espindola-Gomez R, Parra M, Martinez Perez-Crespo P, Ramos-Rincon JM, Fernandez-Pevida A, Lanz-Garcia J, Leon E, Valiente-De-Santis L, Corzo JE, Rodriguez JC, Merino E, Merchante N. Clinical Impact of Implementing a Specific Clinical Pathway for the Management of Clostridioides difficile Infection. Infect Dis Ther. 2026 Jan;15(1):85-100. doi: 10.1007/s40121-025-01261-9. Epub 2025 Nov 7. |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |