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WithdrawnNCT04226001QALYBHReUpdated Nov 17, 2020

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

An observational study in Bacterial Infections, sponsored by Hospices Civils de Lyon. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-17.

Sponsored by Hospices Civils de Lyon · Observational

Why this study was withdrawn
Coordinator departure
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Bacterial Infections
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In context

Infections

6,686 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients infected or colonized by emerging highly resistant bacteria.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients

    Patients screened for carriers infected or colonized by emerging highly resistant bacteria.

    Other: Quality of life questionnaire

Interventions

  • OtherQuality of life questionnaire

    Quality of life questionnaire

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What researchers measure

Primary outcomes

  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

    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).

    Time frame: 12 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04226001
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Jan 13, 2020
Start date
Nov 16, 2020
Primary completion
Feb 2021 (estimated)
Completion
Feb 2021 (estimated)
Last update
Nov 17, 2020

Study contacts

David NARBEY, MD
principal investigator · Hospices Civils de Lyon

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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