BHReICU: Nosocomial Outbreak of BHRe in an Intensive Care Unit During SARS-CoV-2 Pandemic

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05055479
Collaborator
(none)
14
1
6
2.3

Study Details

Study Description

Brief Summary

Multidrug Resistant (MDR) bacteria have become a major worldwide public health challenge and hospitals are now increasingly faced with management of local outbreaks involving such pathogens. Especially, intensive care units (ICU) provide an ideal background for outbreaks caused by MDR bacteria among which carbapenemase-producing Enterobacteriaceae (CPE) can be found. Among CPE involved in ICU outbreaks, VIM producers have been reported worldwide, and described as especially difficult to control. The COVID-19 pandemic and all of the measures health workers have to implement to fight the spread of SARS-Cov-2 have also impacted the management of such outbreaks. In this retrospective study, the investigators aim to describe the management of an outbreak caused by a VIM-producing Enterobacter cloacae strain during the 2020 COVID-19 pandemic in an ICU, and show the importance of concerted measures and actions implemented at multiple levels to prevent the spread of this MDR strain.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Multidrug Resistant (MDR) bacteria have become a major worldwide public health challenge and hospitals are now increasingly faced with management of local outbreaks involving such pathogens. Especially, intensive care units (ICU) provide an ideal background for outbreaks caused by MDR bacteria among which carbapenemase-producing Enterobacteriaceae (CPE) can be found. Among CPE involved in ICU outbreaks, VIM producers have been reported worldwide, and described as especially difficult to control. The COVID-19 pandemic and all of the measures health workers have to implement to fight the spread of SARS-Cov-2 have also impacted the management of such outbreaks. The likely source of an outbreak is not always easy to pinpoint, but some common sources can be cited: an index patient with a history of hospitalization abroad, a contaminated instrument, and/or an environmental reservoir. CPE outbreaks in ICU usually have multifactorial origins, thus needing to combine several actions to be controlled. Infection and prevention control (IPC) measures habitually rely on patients screening, use of contact precautions, staff education, enhanced environmental cleaning, cohorting of patients and staff as well as a proper antimicrobial stewardship. Investigation of these outbreaks and implementation of IPC measures are ensured by various professional categories in the hospital. This implies a tight cooperation and communication between all involved healthcare workers.

    In this retrospective study, the investigators aim to describe the management of an outbreak caused by a VIM-producing Enterobacter cloacae strain during the 2020 COVID-19 pandemic in an ICU, and show the importance of concerted measures and actions implemented at multiple levels to prevent the spread of this MDR strain.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    14 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Nosocomial Outbreak of Monoclonal VIM Carbapenemase Producing Enterobacter Cloacae in an Intensive Care Unit During SARS-CoV-2 Pandemic
    Actual Study Start Date :
    Aug 1, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2022
    Anticipated Study Completion Date :
    Feb 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Change in care type of BHRe in ICU [1 month]

      Management of VIM-producing Enterobacter cloacae strain care in ICU. All types of therapeutics used to manage atrial fibrillation are collected

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients who have stayed in ICU

    • patients with positive sample to E. cloacae VIM between March and October 2020

    Exclusion Criteria:
    • patients who didn't agreed to be included

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens Picardie Amiens Picardie France 80054

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT05055479
    Other Study ID Numbers:
    • PI2021_843_0187
    First Posted:
    Sep 24, 2021
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021