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OpenTrials
Completed

NCT Number: NCT04579094

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes, Hôpital Universitaire Carémeau

Nîmes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Feces sampling at inclusion (J0)

Other

Feces sampling at inclusion (J0)

Primary outcomes

  1. Presence or absence of multi-drug resistant bacteria in residents' feces.

    Time frame: at inclusion (J0)

    prevalence of carriage of multi-drug resistant bacteria

  2. Presence or absence of Highly Resistant and Emerging Bacteria in residents' feces.

    Time frame: at inclusion (J0)

    prevalence of carriage of Highly Resistant and Emerging Bacteria

  3. Presence or absence of Clostridioids difficult toxinogenic in residents' feces.

    Time frame: at inclusion (J0)

    prevalence of carriage of Clostridioids difficult toxinogenic

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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)

Acronym: PREMS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2020
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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