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

Completed

• Conditions: Critical Care; Immunocompromised Host

• Registration Number: NCT04043793
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-02
• Study Start: 2019-11-07
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-07
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 759

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mechanical ventilation duration	From ICU admission until day 28 after ICU admission	the number of days Under mechanical ventilation
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
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
28 day mortality	from ICU admission until day 28 after admission	death in the ICU or after discharge from the ICU
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
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

Trial Locations

Locations (7)

Chu Amiens Picardie; 🇫🇷 Amiens, France

Ch Bethune; 🇫🇷 Béthune, France

CH LENS; 🇫🇷 Lens, France

Grand Hopital de L'Est Francilien; 🇫🇷 Jossigny, France

C.H de Roubaix; 🇫🇷 Roubaix, France

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France