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ASPERGIGRIPP: Invasive Pulmonary Aspergillosis and Severe Influenza

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT04232956
Collaborator
(none)
478
Enrollment
4
Locations
3.3
Actual Duration (Months)
119.5
Patients Per Site
36
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Invasive pulmonary aspergillosis (IPA) has been reported in critically ill patients with influenza infection with a highly variable incidence between 1 to 21%. Studies investigating IPA in critically ill patients with influenza infection suffer limitations in their methods. It remains unknown whether patients with influenza are more at risk of IPA than other patients hospitalized in intensive care unit and whether patients with influenza who develop IPA have specific risk factors for this infection.

Our study aims to determine the incidence of IPA in a large multicenter cohort and to identify risk factors for IPA in these patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    478 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Is Invasive Pulmonary Aspergillosis a Common Complication of Severe Influenza ?
    Actual Study Start Date :
    Jul 27, 2018
    Actual Primary Completion Date :
    Nov 5, 2018
    Actual Study Completion Date :
    Nov 5, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Invasive Pulmonary Aspergillosis [up to 100 days]

      incidence of invasive pulmonary aspergillosis

    Eligibility Criteria

    Criteria

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

    • Infection with influenza A or B

    • Admission to one of the participating sites

    Exclusion Criteria:

    • age < 18

    • patients with invasive pulmonary aspergillosis prior to intensive care admission

    • consent withdraw

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609
    2 CHR Morlaix France
    3 CHU de NANTES Nantes France 44000
    4 CHU de Rennes Rennes France 35033

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT04232956
    Other Study ID Numbers:
    • ASPERGIGRIPP (29BRC18.0069)
    First Posted:
    Jan 18, 2020
    Last Update Posted:
    Jan 18, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Influenza, Human
    Aspergillosis
    Pulmonary Aspergillosis
    Invasive Pulmonary Aspergillosis
    Critical Illness

    Study Results

    No Results Posted as of Jan 18, 2020