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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03401242
Other study ID # RC17_0190
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 3, 2018
Est. completion date January 14, 2019

Study information

Verified date April 2019
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 734
Est. completion date January 14, 2019
Est. primary completion date January 14, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary carbapenemase producing Enterobacteriaceae (CPE) carriage Assessment of CPE carriage through endorectal swabbing. six months
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