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Clinical Trials/NCT04043793
NCT04043793
Completed
Not Applicable

Intensive Care Unit (ICU)-Acquired Colonization and Infection Related to Multidrug Resistant Bacteria (MDR) in Immunocompromised Patients

University Hospital, Lille7 sites in 1 country759 target enrollmentNovember 7, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Immunocompromised Host
Sponsor
University Hospital, Lille
Enrollment
759
Locations
7
Primary Endpoint
Density rate of ICU-acquired infections related to MDR in immunosuppressed patients.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

the number of immunocompromised patients hospitalized in the intensive care units (ICU) is increasing. They are at higher risk of colonization and/or infection with multi-resistant bacteria (MDR). However this risk is not well characterized. ICU acquired infections related to MDR are associated with increased morbidity and mortality. The aim of this study is to compare the incidence of ICU-acquired colonization and ICU-acquired infection related to MDR between immunocompromized and immunocompetent patients. The risk factors for ICU-acquired colonization and ICU-acquired infections, and their impact on outcome will also be evaluated and compared between immunocompromised and immunocompetent patients.

Registry
clinicaltrials.gov
Start Date
November 7, 2019
End Date
December 7, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Expected ICU stay \> 48 hours
  • All patients (immunocompromised or immunocompetent).

Exclusion Criteria

  • Patients aged \< 18 years
  • Refusal to take part in the study
  • ICU-stay \< 48 hours
  • Non availability of initial MDR or subsequent screening
  • Participation in another study that could interfere with the risk of ICU-acquired colonization and infection with MDR bacteria

Outcomes

Primary Outcomes

Density rate of ICU-acquired infections related to MDR in immunosuppressed patients.

Time Frame: From ICU admission until day 28 after ICU admission

the number ICU-acquired infections related to MDR will be devided by the number of days in the ICU and reported for 1000 days.

Secondary Outcomes

  • Mechanical ventilation duration(From ICU admission until day 28 after ICU admission)
  • Density rate of ICU-acquired colonizations related to MDR in immunosuppressed patients(From ICU admission until day 28 after ICU admission)
  • Rate of ICU-acquired colonizations related to MDR in immunosuppressed patients.(From ICU admission until day 28 after ICU admission)
  • 28 day mortality(from ICU admission until day 28 after admission)
  • Rate of ICU-acquired infections related to MDR in immunosuppressed patients(From ICU admission until day 28 after ICU admission)
  • length of stay in intensive care unit(From ICU admission until day 28 after ICU admission)

Study Sites (7)

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