<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03248999</url>
  </required_header>
  <id_info>
    <org_study_id>P/2017/315</org_study_id>
    <nct_id>NCT03248999</nct_id>
  </id_info>
  <brief_title>Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes.</brief_title>
  <acronym>R'EHPAD</acronym>
  <official_title>Determination of the Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes in Franche-Comté (France).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates individual and collective factors of ESBL and CRE carriage in nursing&#xD;
      homes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epimiological data concerning ESBL an CRE, may differ between nursing home and hospital or&#xD;
      community but poor data are available.&#xD;
&#xD;
      Multi-drug resistant bacteria carriage is associated with individual and collective factors&#xD;
      wich have to be defined in nursing homes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2017</start_date>
  <completion_date type="Actual">June 26, 2018</completion_date>
  <primary_completion_date type="Actual">June 26, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ESBL and CRE carriage</measure>
    <time_frame>the day of the study</time_frame>
    <description>number of residents colonized with a extented-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL) or carbapenem-resistant Enterobacteriaceae (CRE)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient and establishment factors associated with ESBL and CRE carriage with a questionnaire</measure>
    <time_frame>the day of the study</time_frame>
    <description>evaluation of risk factors associated with ESBL and CRE carriage and disseminationwith a questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">264</enrollment>
  <condition>Drug Resistance, Bacterial</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>realization of a rectal swab or stool sample for all the résidents included in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>rectal swab</intervention_name>
    <description>stool samples by rectal swab</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  voluntary residents present in the institution on the study day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dement-wandering resident&#xD;
&#xD;
          -  unlikely to cooperate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Céline C Bouvier-Slekovec, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Besançon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>multidrug resistance</keyword>
  <keyword>nursing home</keyword>
  <keyword>ESBL</keyword>
  <keyword>CRE</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03248999
org study id: P/2017/315
nct id: NCT03248999
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates individual and collective factors of ESBL and CRE carriage in nursing
      homes.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: ESBL and CRE carriage
time frame: the day of the study
description: number of residents colonized with a extented-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL) or carbapenem-resistant Enterobacteriaceae (CRE)
measure: patient and establishment factors associated with ESBL and CRE carriage with a questionnaire
time frame: the day of the study
description: evaluation of risk factors associated with ESBL and CRE carriage and disseminationwith a questionnaire.
arm group label: Experimental
arm group type: Experimental
description: realization of a rectal swab or stool sample for all the résidents included in the study.
intervention type: Diagnostic Test
intervention name: rectal swab
description: stool samples by rectal swab
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Céline C Bouvier-Slekovec, Dr
role: Principal Investigator
affiliation: CHU de Besançon
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No