Clinical trial NCT04579094: Prevalence and Risk Factors for the Carriage of Bacteria and Clostridioid in Elderly Dependent Persons
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly
Healthcare Associated Infection
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


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.

Primary outcomes:
measure: Presence or absence of multi-drug resistant bacteria in residents' feces.
timeFrame: at inclusion (J0)
measure: Presence or absence of Highly Resistant and Emerging Bacteria in residents' feces.
timeFrame: at inclusion (J0)
measure: Presence or absence of Clostridioids difficult toxinogenic in residents' feces.
timeFrame: at inclusion (J0)
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes, Hôpital Universitaire Carémeau
Study officials:
References: