NCT05055479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

September 15, 2021

Last Update Submit

November 17, 2025

Conditions

Keywords

outbreakEnterobacteriaceae InfectionsHospital-Acquired Infectionintegrated approachVIM

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • patients who didn't agreed to be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

Related Publications (1)

  • Mullie C, Lemonnier D, Adjide CC, Maizel J, Mismacque G, Cappe A, Carles T, Pierson-Marchandise M, Zerbib Y. Nosocomial outbreak of monoclonal VIM carbapenemase-producing Enterobacter cloacae complex in an intensive care unit during the COVID-19 pandemic: an integrated approach. J Hosp Infect. 2022 Feb;120:48-56. doi: 10.1016/j.jhin.2021.11.017. Epub 2021 Nov 30.

MeSH Terms

Conditions

Enterobacteriaceae InfectionsCross Infection

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

September 24, 2021

Study Start

August 1, 2021

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations