NCT05939479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
644

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

5.3 years

First QC Date

June 23, 2023

Last Update Submit

August 6, 2025

Conditions

Bacterial ResistanceMethicillin-Sensitive Staphylococcus Aureus Infection

Keywords

cefazolinantistaphylococcal penicillinsMethicillin-Sensitive Staphylococcus Aureus InfectionBacterial Resistance

Outcome Measures

Primary Outcomes (1)

  • Association between the cefazolin/antistaphylococcal penicillins consumptions and the resistant bacteria emergence

    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)

    Between the first january 2018 and the 31st december 2022

Secondary Outcomes (4)

  • Factors associated with the emergence of resistant bacteria

    Between the first january 2018 and the 31st december 2022

  • Factors associated with the consumption of antibiotics

    Between the first january 2018 and the 31st december 2022

  • Evolution of resistance in French hospitals

    Between the first january 2018 and the 31st december 2022

  • Evolution of antibiotics consumption in French hospitals

    Between the first january 2018 and the 31st december 2022

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients hospitalized in included French hospitals

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lefevre

Nancy, Lorraine, 54500, France

Location

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in the field of infectious diseases (MD PhD)

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 11, 2023

Study Start

January 1, 2018

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)