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

NCT04579094 | Completed

• 1 other identifier: LOCAL/2019/JO-01
• Study Type: observational
• Target: 492
• Locations: 1 country
• Sites: 1

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

Conditions

Elderly; Healthcare Associated Infection

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

1/elderly dependent persons

Other: Feces sampling at inclusion (J0)

2/healthcare workers (HCW)

Other: Feces sampling at inclusion (J0)

Interventions

Feces sampling at inclusion (J0) OTHER

Feces sampling at inclusion (J0)

1/elderly dependent persons; 2/healthcare workers (HCW)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Resident :
• The resident refuses to participate.
• o healthcare workers : The healthcare workers refuses to participate.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes, Hôpital Universitaire Carémeau

Nîmes, France

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: May 25, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

FR (1)