NCT04226001

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

November 16, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

January 9, 2020

Last Update Submit

November 16, 2020

Conditions

Outcome Measures

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).

    12 months

Study Arms (1)

Patients

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

Other: Quality of life questionnaire

Interventions

Quality of life questionnaire

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients infected or colonized by emerging highly resistant bacteria.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • David NARBEY, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

November 16, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

November 17, 2020

Record last verified: 2020-11