NCT04801862

Natural History of Clostridioides Difficile Infection

Status unknown Last updated 6 March 2024

What this trial tests

trial in Clostridium Difficile Infection in 750 participants. Status unknown.

Timeline

1 January 2021

Primary endpoint
30 June 2024

31 December 2024

Quick facts

Lead sponsor	Hospital Universitario de Valme
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	750
Start date	1 January 2021
Primary completion	30 June 2024
Estimated completion	31 December 2024
Sites	15 locations across Spain

Conditions studied

• Clostridium Difficile Infection — all drugs for Clostridium Difficile Infection →
• Health Care Associated Infection — all drugs for Health Care Associated Infection →
• Nosocomial Infection — all drugs for Nosocomial Infection →

Sponsor

Hospital Universitario de Valme

Who can join

18 and older, any sex, with Clostridium Difficile Infection or Health Care Associated Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of COVID19 pandemic on the incidence of health-care associated Clostridioides difficile infection.
   Merchante N, Chico P, Márquez-Saavedra E, Riera G, et al · · 2022 · cited 13× · PMID 35500744 · DOI 10.1016/j.anaerobe.2022.102579
2. Role of previous systemic antibiotic therapy on the probability of recurrence after an initial episode of <i>Clostridioides difficile</i> infection treated with vancomycin.
   Merchante N, Herrero R, Valverde-Fredet MD, Rodríguez-Fernández M, et al · · 2023 · cited 2× · PMID 36968953 · DOI 10.1093/jacamr/dlad033
3. Dynamics of the microbiota in patients with Clostridioides difficile: Recurrence, treatment, sex, and immunosuppression.
   Ventero MP, Herrero R, Tyshkovska I, Valverde-Fredet MD, et al · · 2026 · cited 1× · PMID 41941490 · DOI 10.1371/journal.ppat.1014063
4. Clinical Impact of Implementing a Specific Clinical Pathway for the Management of Clostridioides difficile Infection.
   Rodríguez-Fernández M, Herrero R, González-De-La-Aleja P, Valverde-Fredet MD, et al · · 2026 · cited 1× · PMID 41201562 · DOI 10.1007/s40121-025-01261-9
5. Antimicrobial Susceptibility of &lt;i&gt;Clostridioides difficile&lt;/i&gt; in Spain: Multicenter Retrospective Cohort Study.
   Ventero MP, Valverde-Fredet MD, Merino E, Herrero R, et al · · 2026 · PMID 41750443 · DOI 10.3390/antibiotics15020145
6. Antimicrobial Susceptibility of Clostridioides difficile in Spain: Multicenter Retrospective Cohort Study
   Ventero M, Valverde-Fredet M, Merino E, Herrero R, et al · · 2026