Prevalence and Risk Factors for the Carriage of Bacteria... | NCT04579094

Studies
Prevalence and Risk Factors for the Carriage of Bacteria and Clostridioid in Elderly Dependent Persons

NCT04579094

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

May 28, 2025Actual

Enrollment

492Actual

Phase

Not provided

Conditions

Elderly
Healthcare Associated Infection

Interventions

Feces sampling at inclusion (J0)

Countries

France

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

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2022Actual

Primary Completion Date

Sep 30, 2024Actual

Completion Date

Sep 30, 2024Actual

First Submitted Date

Oct 1, 2020

First Submission Date that Met QC Criteria

Oct 1, 2020

First Posted Date

Oct 8, 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

May 26, 2025

Last Update Posted Date

May 28, 2025Actual

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

Brief summary : Very few studies have evaluated the prevalence of multi-drug resistant (MDR), highly resistant emerging bacteria and Clostridioides difficile toxinogenic (CDt) in residents and in healthcare workers (HCW) in nursing home (NH). Most of study were conducted in acute care services and were limited to specific bacterial species.

Hypothesis : The carriage of MDR bacteria in resident may be a risk factor for an outbreak in NH or in healthcare facility.

Primary outcome: The objective of this study is to estimate the prevalence for carriage of MDR bacteria and CDt in residents in NH.

Secondary outcomes:

Estimate the prevalence for carriage of MDR bacteria and CDt toxigenic in HCW in NH.
Identify the risk factors for carriage of MDR bacteria and CDt in residents in nursing home
Identify the risk factors for carriage of MDR bacteria and CDt in healthcare workers in NH
Evaluate the presence of cross-transmission of MDR bacteria and CDt in one or several NH
Evaluate the association between the presence of cross-transmission of MDR bacteria and CDt in a NH and the management of infection control
Establishment a collection of stool samples

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

492Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1/elderly dependent persons			Other: Feces sampling at inclusion (J0)
2/healthcare workers (HCW)			Other: Feces sampling at inclusion (J0)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Feces sampling at inclusion (J0)	Other	Feces sampling at inclusion (J0)	1/elderly dependent persons 2/healthcare workers (HCW)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence or absence of multi-drug resistant bacteria in residents' feces.	prevalence of carriage of multi-drug resistant bacteria	at inclusion (J0)
Presence or absence of Highly Resistant and Emerging Bacteria in residents' feces.	prevalence of carriage of Highly Resistant and Emerging Bacteria	at inclusion (J0)
Presence or absence of Clostridioids difficult toxinogenic in residents' feces.	prevalence of carriage of Clostridioids difficult toxinogenic	at inclusion (J0)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:
Resident :

The resident must be a member or beneficiary of a health insurance. The resident is in permanent accommodation whose the date of admission is at least 1 month earlier on the day of collection.

healthcare workers : The healthcare workers must be a member or beneficiary of a health insurance. The healthcare workers begin to work in nursing at least 1 month earlier on the day of collection.
Exclusion criteria:
Resident :

The resident refuses to participate.

o healthcare workers : The healthcare workers refuses to participate.

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

The target population of the study is all elderly residents of nursing home and their caregivers. The source population of the study corresponds to the residents of the 61 nursing home in the Gard region, and their caregivers.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nîmes, Hôpital Universitaire Carémeau		Nîmes			France

Condition Browse Module

MeSH Terms

ID	Term
D003428	Cross Infection

Ancestor Terms

ID	Term
D007239	Infections
D007049	Iatrogenic Disease
D020969	Disease Attributes
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

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