Natural History of Clostridioides Difficile Infection

Sponsor

Hospital Universitario de Valme (Other)

Overall Status

Recruiting

CT.gov ID

NCT04801862

Collaborator

(none)

750

Enrollment

Locations

35.9

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clostridium Difficile Infection Health Care Associated Infection Nosocomial Infection

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

750 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical, Microbiological and Genetic Factors Associated With Recurrence of Clostridioides Difficile Infection and Development of a Predictive Tool for Recurrence

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients diagnosed of C.difficile infection Open cohort of consecutive patients diagnosed of Clostridioides difficile infection

Outcome Measures

Primary Outcome Measures

CDI recurrence [First 8 weeks after end of therapy]
Clostridioides difficile recurrence
CDI reinfection [Between 8 weeks after end of therapy and before 24 weeks]
New episode of Clostridioides difficile infection

Secondary Outcome Measures

Readmission due to CDI infection [During 24 weeks after the end of therapy]
New hospitalization related to new Clostridioides difficile infection episode

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age older than 18 years
New episode of Clostridioides difficile infection, based on IDSA criteria.

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Vega Baja	Orihuela	Alicante	Spain
2	Hospital Marina Baixa	Villajoyosa	Alicante	Spain
3	Hospital Universitario de Puerto Real	Puerto Real	Cadiz	Spain
4	Hospital General Universitario de Alicante	Alicante		Spain
5	Hospital Universitario San Juan	Alicante		Spain
6	Hospital Universitario Reina Sofía	Córdoba		Spain
7	Hospital Universitario San Cecilio	Granada		Spain
8	Hospital Juan Ramón Jiménez	Huelva		Spain
9	Hospital Regional Universitario de Málaga	Málaga		Spain
10	Hospital Universitario Virgen de la Victoria	Málaga		Spain
11	Hospital Universitario de Valme	Sevilla		Spain
12	Hospital Universitario Virgen Macarena	Sevilla		Spain
13	Consorcio Hospital General de Valencia	Valencia		Spain
14	Hospital Clínico Universitario de Valencia	Valencia		Spain
15	Hospital Politécnico Universitario La Fe de Valencia	Valencia		Spain