Clinical trial NCT03401242: Prevalence of ESBL and CPE in French Nursing Homes
Official title: Investigation of the Prevalence of Fecal Carriage of Extended Spectrum bêta-lactamase Producing Enterobacteriaceae (ESBL) and Carbapenemase Producing Enterobacteriaceae (CPE) in Nursing Homes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enterobacteriaceae Infections
Keywords: Carbapenemase
Enterobacteriaceae
extended spectrum beta-lactamases
nursing homes
prevalence
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 734
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: carbapenemase producing Enterobacteriaceae (CPE) carriage
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Gabriel BIRGAND, Dr
role: PRINCIPAL_INVESTIGATOR
References: