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

Sponsor
University Hospital, Lille (Other)
Overall Status
Unknown status
CT.gov ID
NCT04043793
Collaborator
(none)
709
Enrollment
1
Location
11.8
Anticipated Duration (Months)
60.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    709 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Intensive Care Unit (ICU)-Acquired Colonization and Infection Related to Multidrug Resistant Bacteria (MDR) in Immunocompromised Patients
    Actual Study Start Date :
    Oct 8, 2019
    Anticipated Primary Completion Date :
    Oct 1, 2020
    Anticipated Study Completion Date :
    Oct 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    4. 28 day mortality [from ICU admission until day 28 after admission]

      death in the ICU or after discharge from the ICU

    5. Mechanical ventilation duration [From ICU admission until day 28 after ICU admission]

      the number of days Under mechanical ventilation

    6. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Roger Salengro, CHU Lille France

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Saad NSEIR, MD, PhD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT04043793
    Other Study ID Numbers:
    • 2018_07
    • 2018-A02756-49
    First Posted:
    Aug 2, 2019
    Last Update Posted:
    Nov 19, 2019
    Last Verified:
    Nov 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    Immunocompromised Host
    Critical care
    Drug Resistance, Multiple
    Additional relevant MeSH terms:
    Infections

    Study Results

    No Results Posted as of Nov 19, 2019