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

Elderly Clinical Trial

— PREMS  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04579094
• Other study ID #: LOCAL/2019/JO-01
• Status: Recruiting
• Start date: May 25, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Jérôme Ory, MD
• Phone: 04.66.68.32.02
• Email: jerome.ory[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Cross Infection
• Elderly
• Healthcare Associated Infection

Intervention

Other:
• Feces sampling at inclusion (J0)
Feces sampling at inclusion (J0)

Locations

Country	Name	City	State
France	CHU de Nîmes, Hôpital Universitaire Carémeau	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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