CePasR: Antistaphylococcal Betalactam and Emergence of Resistance

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT05939479
Collaborator
(none)
644
1
65
9.9

Study Details

Study Description

Brief Summary

Antistaphylococcal penicillins are recommanded as first-line agent in methicillin-suceptible Staphylococcus aureus bacteraemia. Several studies in progress are investigating the efficacy and safety of cefazolin compared with antistaphylococcal penicillins. Cefazolin has broader spectrum than antistaphylococcal penicillins. The hypothesis of this project is that cefazoline could be responsible for a higher rate of bacterial resistance. The aim is to study the association between the emergence of bacterial resistance and the consumption of cefazolin and antistaphylococcal penicillins.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    644 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Retrospective
    Official Title:
    Impact of Antistaphylococcal Penicillins and Cefazolin on the Emergence of Resistance in French Hospitals
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    May 1, 2023
    Actual Study Completion Date :
    Jun 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Association between the cefazolin/antistaphylococcal penicillins consumptions and the resistant bacteria emergence [Between the first january 2018 and the 31st december 2022]

      The total consumption of antibiotics (expressed as number of Defined Daily Doses (DDD) per 1000 inhabitants per day) will be correlate with the resistant bacteria emergence (only incidence for each bacterial strain)

    Secondary Outcome Measures

    1. Factors associated with the emergence of resistant bacteria [Between the first january 2018 and the 31st december 2022]

      Factors associated with the emergence of resistant bacteria will be described by a Cox model: hospital size (number of beds), location in France, activities (intensive care, surgery, etc.), type of antibiotics and intensity of consumption expressed in number of defined daily doses (DDD).

    2. Factors associated with the consumption of antibiotics [Between the first january 2018 and the 31st december 2022]

      Factors associated with the emergence of resistant bacteria will be described by a Cox model: hospital size (number of beds), location in France, activities (intensive care, surgery, etc.) and type of bacterial strain indentified (resistant or not).

    3. Evolution of resistance in French hospitals [Between the first january 2018 and the 31st december 2022]

      For each year, bacterial resistance will be described, in France and in each hospital, in the form of a quantitative variable: number of resistant bacterial strains isolated for each year (number of resistant strains / total number of strains).

    4. Evolution of antibiotics consumption in French hospitals [Between the first january 2018 and the 31st december 2022]

      For each year, antibiotic consumption will be described, in France and in each hospital, in the form of a quantitative variable (expressed as number of Defined Daily Doses (DDD) per 1000 inhabitants per day)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: French hospitals which have collected their consumption and resistance data on the French national database named CONSORES (From 2019 to 2022)

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lefevre Nancy Lorraine France 54500

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LEFEVRE Benjamin, M.D., Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT05939479
    Other Study ID Numbers:
    • 2023PI051
    First Posted:
    Jul 11, 2023
    Last Update Posted:
    Jul 11, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by LEFEVRE Benjamin, M.D., Central Hospital, Nancy, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 11, 2023