PREdiction of CEphalosporinase Producing Enterobacteria During Ventilator-associated Pneumonia for Therapeutic Stewardship

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Recruiting
CT.gov ID
NCT05486130
Collaborator
(none)
800
1
5.5
146.7

Study Details

Study Description

Brief Summary

Ventilator-associated pneumonia is the leading cause of nosocomial infection in the ICU. Cephalosporinase-producing Enterobacteriaceae have an increasing incidence. Infections in cephalosporinase-producing patients require the use of Cefepime during probabilistic antibiotic therapy, the repeated use of which will lead to a significant risk of selection of resistant mutants. The involvement of cephalosporinases being infrequent, the prediction of their presence during a VAP would make it possible to reduce the consumption of Cefepime and thus to take part in the prevention of selection of bacterial mutants resistant to beta-lactams. The main objective of the research is to determine the risk factors for the involvement of cephalosporinase-producing enterobacteria during episodes of ventilator-associated pneumonia (VAP) in hospitalized patients. The secondary objectives are to describe the epidemiology of cephalosporinase-producing enterobacteria in the ICU and to compare the risk factors for the presence of a cephalosporinase-producing germ not without its production being derepressed with those present in situations of cephalosporinase derepression.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    PREdiction of CEphalosporinase Producing Enterobacteria During Ventilator-associated Pneumonia for Therapeutic Stewardship
    Actual Study Start Date :
    Jul 18, 2022
    Anticipated Primary Completion Date :
    Aug 18, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of cephalosporinase-producing enterobacteria during episodes of ventilator-associated pneumonia [1 month]

      This outcome corresponds to the the number of ventilator-associated pneumonias involving cephalosporinase-producing enterobacteria.

    Secondary Outcome Measures

    1. Epidemiology of cephalosporinase-carrying enterobacteria in the ICU [1 month]

      This outcome corresponds to the number of pathogens identified in ventilator-associated pneumonia.

    Eligibility Criteria

    Criteria

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

    • Patient on mechanical ventilation for more than 48 hours

    • Patient with a diagnosis of ventilator-associated lung disease during management according to American Thoracic Society criteria

    • French speaking patient

    Exclusion Criteria:
    • Tracheostomized patient at the time of inclusion

    • Limitation of therapies before inclusion in the study

    • Patient under guardianship or curatorship

    • Patient deprived of liberty

    • Patient under court protection

    • Patient objecting to the use of his/her data for this research

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint-Joseph Paris France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Principal Investigator: François PHILIPPART, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT05486130
    Other Study ID Numbers:
    • PRECEPT
    First Posted:
    Aug 3, 2022
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2022