Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes. (R'EHPAD)

December 5, 2018 updated by: Centre Hospitalier Universitaire de Besancon

Determination of the Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes in Franche-Comté (France).

This study evaluates individual and collective factors of ESBL and CRE carriage in nursing homes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epimiological data concerning ESBL an CRE, may differ between nursing home and hospital or community but poor data are available.

Multi-drug resistant bacteria carriage is associated with individual and collective factors wich have to be defined in nursing homes.

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • CHU Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • voluntary residents present in the institution on the study day

Exclusion Criteria:

  • dement-wandering resident
  • unlikely to cooperate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
realization of a rectal swab or stool sample for all the résidents included in the study.
Diagnostic test: rectal swab
stool samples by rectal swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ESBL and CRE carriage
Time Frame: the day of the study
number of residents colonized with a extented-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL) or carbapenem-resistant Enterobacteriaceae (CRE)
the day of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient and establishment factors associated with ESBL and CRE carriage with a questionnaire
Time Frame: the day of the study
evaluation of risk factors associated with ESBL and CRE carriage and disseminationwith a questionnaire.
the day of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Céline C Bouvier-Slekovec, Dr, CHU de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Actual)

June 26, 2018

Study Completion (Actual)

June 26, 2018

Study Registration Dates

First Submitted

August 2, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P/2017/315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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