Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 11:44 AM
Study NCT ID:
NCT04579094
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2020-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Risk Factors for the Carriage of Bacteria and Clostridioid in Elderly Dependent Persons
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREMS
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: