- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07920627
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care. (EpiCE)
Clostridioides difficile infection (CDI) is the leading cause of infectious diarrhea among older adults. The epidemiology of community-acquired CDI, particularly among residents of long-term care facilities, remains poorly understood to this day. While numerous studies on the epidemiology, prevention, diagnosis, and treatment of CDI have been conducted in hospital settings, primary care often lags behind these advances. Limited access to diagnostic tests and treatment options, as well as insufficient resources allocated to preventing cross-transmission, are all factors that hinder the control of ICD in long-term care facilities. This will be the first French study on the epidemiology of ICD among nursing home residents, which can serve as a reference for implementing a multidisciplinary action plan and measuring its impact. This will be carried out as part of a city-hospital collaboration and will facilitate the creation of a healthcare network involving multiple healthcare providers, such as general practitioners working in nursing homes, clinical laboratories, pharmacies, dietitians and nutritionists, and the university hospital.
A better understanding of the epidemiology of ICD among residents in long-term care facilities and an assessment of professional practices related to ICD risk prevention should enable us to better target strategies for improving care while raising awareness among healthcare providers and public health policymakers. We therefore plan to optimize the impact of implementing a multidisciplinary action program aligned with the expectations of frontline practitioners regarding the reduction of the risk of ICD (training, prevention tools, diagnosis and treatment of ICD, appropriate use of antibiotics, nutritional counseling, prescribing probiotics, and establishing a coordinated care pathway for ICD). The implementation of this action program is expected to reduce the incidence rate of ICD, the recurrence rate, and antibiotic use in nursing homes, as well as the number of transfers to the hospital for ICD management.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Marseille, France
- Assistance Publique Hopitaux de Marseille
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
residents of nursing homes
Description
Inclusion Criteria:
- Men or women aged 65 or older
- Patients who have received information about the study and have not expressed objection
- Residents of the nursing home for more than 72 hours during the 12-month enrollment period
- No objection to the use of clinical and biological data in the event of an ICD.
Exclusion Criteria:
- A patient who is in the exclusion period of another research protocol at the time the informed consent form is obtained.
- A person who does not understand French
- No inclusion criteria.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence Rate of ICD
Time Frame: 24 MONTHS
|
|
24 MONTHS
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the recurrence rate of C. difficile colitis
Time Frame: 24 MONTHS
|
24 MONTHS
|
|
Measuring the Use of Critical Antibiotics
Time Frame: 24 MONTHS
|
24 MONTHS
|
|
Measure the number of hospital transfers for ICD management.
Time Frame: 24 MONTHS
|
24 MONTHS
|
|
the prevalence of the main risk factors for ICD
Time Frame: 24MONTHS
|
24MONTHS
|
Collaborators and Investigators
Investigators
- Principal Investigator: cassir nadim, assistance publique hôpitaux de Marseille
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCAPHM26_0189
- PADS26-262 (Other Identifier: APHM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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