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

Nosocomial Outbreak of Monoclonal VIM Carbapenemase Producing Enterobacter Cloacae in an Intensive Care Unit During SARS-CoV-2 Pandemic

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.

Study Overview

• Status: Completed
• Conditions: Enterobacteriaceae Infections; Hospital-Acquired Infection

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 Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

• Study Contact: Name: Delphine Lemonnier, MD; Phone Number: 03 22 66 82 22; Email: Lemonnier.delphine@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who have stayed in ICU and with positive sample to E. cloacae VIM between March and October 2020.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in care type of BHRe in ICU	Management of VIM-producing Enterobacter cloacae strain care in ICU. All types of therapeutics used to manage atrial fibrillation are collected	1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Enterobacteriaceae Infections; outbreak; Hospital-Acquired Infection; integrated approach; VIM
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Enterobacteriaceae Infections
• Other Study ID Numbers: PI2021_843_0187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No