Prevalence and Risk Factors for the Carriage of Bacteria and Clostridioid in Elderly Dependent Persons (PREMS)

Prevalence and Risk Factors for the Carriage of Multi- and Highly Resistant Bacteria and Clostridioid Difficile Toxigenic in Residents and Healthcare Workers in Nursing Home (PREMS)

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

Study Overview

• Status: Completed
• Conditions: Elderly; Healthcare Associated Infection
• Intervention / Treatment: Other: Feces sampling at inclusion (J0)

• Study Type: Observational
• Enrollment (Actual): 492

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nîmes, Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1/elderly dependent persons	Other: Feces sampling at inclusion (J0); Feces sampling at inclusion (J0)
2/healthcare workers (HCW)	Other: Feces sampling at inclusion (J0); Feces sampling at inclusion (J0)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Iatrogenic Disease; Cross Infection
• Other Study ID Numbers: LOCAL/2019/JO-01

Drug and device information, study documents

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