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Impact of a Carrier (Infection, Colonization) of Highly Bacteria Resistance on the Patient's Quality of Life Hospital Environment (QALYBHRe)

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ClinicalTrials.gov Identifier: NCT04226001
Recruitment Status : Withdrawn (Coordinator departure)
First Posted : January 13, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
The quality of life of carriers detected infected or colonized by emerging highly resistant bacteria (BHRe) following the implementation of specific hygiene measures during the discovery of the microorganism has been little studied. To date, there have been no studies to determine the quality of life (QoL) in France of patients with hospitalized HBHRD.

Condition or disease Intervention/treatment
Bacterial Infections Other: Quality of life questionnaire

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of a Carrier (Infection, Colonization) of Highly Bacteria Resistance on the Patient's
Actual Study Start Date : November 16, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Group/Cohort Intervention/treatment
Patients
Patients screened for carriers infected or colonized by emerging highly resistant bacteria.
Other: Quality of life questionnaire
Quality of life questionnaire




Primary Outcome Measures :
  1. Impact of the implementation of Complementary Hygiene Precautions following a carrier of emerging highly resistant bacteria on the quality of life of hospitalized patients [ Time Frame: 12 months ]
    Measurement of the decrease in utility corresponding to the deterioration of the QOL of patients since the implementation of the Additional Hygiene Precautions (PCH) following the discovery of their emerging highly resistant bacteria (BHRe).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients infected or colonized by emerging highly resistant bacteria.
Criteria

Inclusion Criteria:

  • Age> 18 years old
  • Have a positive BHRe screening during the hospital stay and / or have a positive BHRe clinical sample during the hospital stay
  • Conscious patients
  • All types of stays in the hospital sector
  • All pathologies

Exclusion Criteria:

  • Known patients with BHRe before hospitalization
  • PCH immediately upon admission (history of hospitalization abroad, patients contacted during a previous hospitalization)
  • Cognitive problem
  • Patients not proficient in French (requiring an interpreter)
  • Patients under guardianship

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): NCT04226001


Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: David NARBEY, MD Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04226001    
Other Study ID Numbers: 69HCL19_0022
2019-A00074-53 ( Other Identifier: ID-RCB )
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Bacterial Infections
Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses