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

Impact of a Carrier (Infection, Colonization) of Highly Bacteria Resistance on the Patient's

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.

Study Overview

• Status: Withdrawn
• Conditions: Bacterial Infections
• Intervention / Treatment: Other: Quality of life questionnaire

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients infected or colonized by emerging highly resistant bacteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of the implementation of Complementary Hygiene Precautions following a carrier of emerging highly resistant bacteria on the quality of life of hospitalized patients	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).	12 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: David NARBEY, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2020
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): February 1, 2021

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (ACTUAL): January 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections
• Other Study ID Numbers: 69HCL19_0022; 2019-A00074-53 (OTHER: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No