Clinical trial NCT04043793: ICU-acquired Colonization and Infection Related to MDR in Immunocompromised Patients
Official title: Intensive Care Unit (ICU)-Acquired Colonization and Infection Related to Multidrug Resistant Bacteria (MDR) in Immunocompromised Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunocompromised Host
Critical Care
Keywords: Immunocompromised Host
Critical care
Drug Resistance, Multiple
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: immunocompetent patients, and immunocompromised patients admitted to intensive care

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.


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

Primary outcomes:
measure: Density rate of ICU-acquired infections related to MDR in immunosuppressed patients.
timeFrame: From ICU admission until day 28 after ICU admission
Secondary outcomes:
measure: Density rate of ICU-acquired colonizations related to MDR in immunosuppressed patients
timeFrame: From ICU admission until day 28 after ICU admission
measure: Rate of ICU-acquired colonizations related to MDR in immunosuppressed patients.
timeFrame: From ICU admission until day 28 after ICU admission
measure: Rate of ICU-acquired infections related to MDR in immunosuppressed patients
timeFrame: From ICU admission until day 28 after ICU admission
measure: 28 day mortality
timeFrame: from ICU admission until day 28 after admission
measure: Mechanical ventilation duration
timeFrame: From ICU admission until day 28 after ICU admission
measure: length of stay in intensive care unit
timeFrame: From ICU admission until day 28 after ICU admission
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens Picardie
city: Béthune
country: France
facility: Ch Bethune
city: Jossigny
country: France
facility: Grand Hopital de L'Est Francilien
city: Lens
country: France
facility: CH LENS
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Roubaix
country: France
facility: C.H de Roubaix
Study officials:
affiliation: University Hospital, Lille
name: Saad NSEIR, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: