ICU-acquired Colonization and Infection Related to MDR in Immunocompromised Patients (CIMDREA)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Care; Immunocompromised Host

• Study Type: Observational
• Enrollment (Actual): 759

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens Picardie
  • Béthune, France
    • CH Béthune
  • Jossigny, France
    • Grand Hôpital de l'Est Francilien
  • Lens, France
    • CH Lens
  • Lille, France
    • Hôpital Roger Salengro, CHU
  • Lyon, France
    • Hospices Civils de Lyon
  • Roubaix, France
    • C.H de Roubaix

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: Probability Sample

Study Population

immunocompetent patients, and immunocompromised patients admitted to intensive care

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Density rate of ICU-acquired infections related to MDR in immunosuppressed patients.	the number ICU-acquired infections related to MDR will be devided by the number of days in the ICU and reported for 1000 days.	From ICU admission until day 28 after ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Density rate of ICU-acquired colonizations related to MDR in immunosuppressed patients	the number of ICU-acquired colonizations related to MDR will be devided by the number of days in the ICU and reported for 1000 days	From ICU admission until day 28 after ICU admission
Rate of ICU-acquired colonizations related to MDR in immunosuppressed patients.	The rate of patients with at least one ICU-acquired colonization related to MDR	From ICU admission until day 28 after ICU admission
Rate of ICU-acquired infections related to MDR in immunosuppressed patients	The rate of patients with at least one ICU-acquired infection related to MDR	From ICU admission until day 28 after ICU admission
28 day mortality	death in the ICU or after discharge from the ICU	from ICU admission until day 28 after admission
Mechanical ventilation duration	the number of days Under mechanical ventilation	From ICU admission until day 28 after ICU admission
length of stay in intensive care unit	the number of days of hospitalization in teh ICU	From ICU admission until day 28 after ICU admission

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2019
• Primary Completion (Actual): December 7, 2021
• Study Completion (Actual): December 7, 2021

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Critical care; Immunocompromised Host; Drug Resistance, Multiple
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 2018_07; 2018-A02756-49 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No