- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03401242
Prevalence of ESBL and CPE in French Nursing Homes (CARBEHPAD)
Investigation of the Prevalence of Fecal Carriage of Extended Spectrum bêta-lactamase Producing Enterobacteriaceae (ESBL) and Carbapenemase Producing Enterobacteriaceae (CPE) in Nursing Homes
CARBEHPAD is a multicentric randomized prevalence study aiming to assess the frequency of Enterobacteriaceae (ESLB) and carbapenemase producing Enterobacteriaceae (CPE) carriage in Pays de la Loire nursing homes.
A sample of 50 nursing homes (NH) in Pays de la Loire will be randomly selected for inclusion, and a sample of 1/3 of residents of these NH will be screened for ESBL and/or CPE fecal carriage. Epidemiological data on each resident will be collected to identify risk factors for such carriage.
Study Overview
Status
Conditions
Detailed Description
The Pays de la Loire region is impacted by 2 main CPE outbreaks in the 2 major university hospitals in this region. A sample of 50 nursing homes (NH) in Pays de la Loire region (France) will be randomly selected for inclusion in CARBEHPAD study. NH directors will be contacted for agreement for inclusion in CARBEHPAD study. In each of the included NH, a sample of one third of residents will be randomly selected for inclusion. Upon agreement, each resident included will be screened through endorectal swabbing for ESBL and/or CPE carriage.
Epidemiological data will be collected for each resident regarding demographic data, risk factors for ESBL and/or CPE carriage, comorbidities. These data collected in the NH will be completed with data collection from national NH database regarding: previous hospitalization, treatments (including antibiotics), surgery.
Data on infection control and prevention will be collected in each NH to assess cross transmission of resistant bacteria in these settings.
Comparison of isolated strains will be performed to assess clonal dissemination of these resistant Enterobacteriaceae in NH. Data regarding infection control and prevention in each included NH will be collected aswell.
An ESBL/CPE carrier status has no impact on medical care in NH regarding French recommendations on management of such resistant microorganisms.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nantes, France, 44093
- Nantes University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
1000 residents of the nursing homes of the 5 departments of Pays de la Loire will be included in this study protocol.
Participants in the study will be randomly sampled according to a two-stage sampling design.
Description
Inclusion Criteria:
- Resident present in the nursing home on the day of the survey.
- Resident having agreed to be included in the study.
- Resident with a social security number.
Exclusion Criteria:
- Resident non-compliant with sampling protocol.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
carbapenemase producing Enterobacteriaceae (CPE) carriage
Time Frame: six months
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Assessment of CPE carriage through endorectal swabbing.
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six months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gabriel BIRGAND, Dr, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC17_0190
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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