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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248999
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

Condition or disease Intervention/treatment Phase
Drug Resistance, Bacterial Diagnostic Test: rectal swab Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determination of the Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes in Franche-Comté (France).
Actual Study Start Date : November 20, 2017
Actual Primary Completion Date : June 26, 2018
Actual Study Completion Date : June 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • voluntary residents present in the institution on the study day

Exclusion Criteria:

  • dement-wandering resident
  • unlikely to cooperate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248999


Locations
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France
CHU Besançon
Besançon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Céline C Bouvier-Slekovec, Dr CHU de Besançon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03248999    
Other Study ID Numbers: P/2017/315
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
multidrug resistance
nursing home
ESBL
CRE