Impact of a Carrier (Infection, Colonization) of Highly B... | NCT04226001

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

NCT04226001

Sponsor

Hospices Civils de Lyon

Status

Withdrawn

Last Update Posted

Nov 17, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Bacterial Infections

Interventions

Quality of life questionnaire

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-A00074-53	Other Identifier	ID-RCB

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Coordinator departure

Expanded Access Info

Start Date

Nov 16, 2020Actual

Primary Completion Date

Feb 2021Estimated

Completion Date

Feb 2021Estimated

First Submitted Date

Jan 9, 2020

First Submission Date that Met QC Criteria

Jan 9, 2020

First Posted Date

Jan 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2020

Last Update Posted Date

Nov 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Patients screened for carriers infected or colonized by emerging highly resistant bacteria.	Other: Quality of life questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quality of life questionnaire	Other	Quality of life questionnaire	Patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients infected or colonized by emerging highly resistant bacteria.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
David NARBEY, MD	Hospices Civils de Lyon	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D001424	Bacterial Infections

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided