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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04043793

Acronym

CIMDREA

Enrollment

759

Registered

2019-08-02

Start date

2019-11-07

Completion date

2021-12-07

Last updated

2022-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Immunocompromised Host

Keywords

Immunocompromised Host, Critical care, Drug Resistance, Multiple

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Density rate of ICU-acquired infections related to MDR in immunosuppressed patients.	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

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

Countries

France

Outcome results