NCT07186894

Brief Summary

Background Methicillin-susceptible Staphylococcus aureus (MSSA) bacteraemia is a common and serious infection, associated with significant morbidity and high mortality rates. Antistaphylococcal penicillins (ASPs) have traditionally been recommended as the first-line treatment. However, this established position has recently been challenged by meta-analyses suggesting that cefazolin may provide comparable efficacy, along with a more favourable safety profile. Further clinical and real-world studies are warranted to substantiate these findings. Objectives The aim of this study was to assess the effectiveness and safety of cefazolin compared with ASPs in the management of MSSA bacteraemia.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jan 2000

Longer than P75 for all trials

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jan 2000Sep 2026

Study Start

First participant enrolled

January 1, 2000

Completed
25.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

26.7 years

First QC Date

September 16, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

Methicillin-susceptible Staphylococcus aureusbacteremiaantistaphylococcal penicillinscefazolinreal-word evaluationTriNetX

Outcome Measures

Primary Outcomes (1)

  • 90 days all-cause mortality

    All-cause mortality, at day 90

    90 days after the inclusion

Secondary Outcomes (2)

  • All-cause mortality measured at other timeframes

    day 7, day 30, and 1 year

  • Safety outcomes

    30 or 90 days after the inclusion

Study Arms (2)

Antistaphylococcal penicillins (ASPs)

ASPs group Inclusion criteria * Monobacterial methicillin susceptible Staphylococcus aureus (MSSa) bacteremia * Antistaphylococcal penicillins (ASPs) injectable prescription (flucloxacillin, floxacillin, cloxacillin, oxacillin, nafcillin and dicloxacillin) in the week before or the week after MSSa bacteremia Exclusion criteria : cefazolin injectable prescription in the year before or the year after MSSa bacteremia

Drug: Antistaphylococcal penicillins

Cefazolin

Cefazolin group Inclusion criteria * Monobacterial methicillin susceptible Staphylococcus aureus (MSSa) bacteremia * Cefazolin injectable prescription in the week before or the week after MSSa bacteremia Exclusion criteria : ASP injectable prescription in the year before or the year after MSSa bacteremia

Drug: Cefazolin

Interventions

It in not an interventional study. This project is a phase IV, retrospective, descriptive, and multicentric study.

Antistaphylococcal penicillins (ASPs)

It in not an interventional study. This project is a phase IV, retrospective, descriptive, and multicentric study.

Cefazolin

Eligibility Criteria

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

Variables : age, sex, medical history, type of infection and antibiotic used. Variables will be described as number and percentage for categorical variables, and mean and standard-deviation for continuous ones. A propensity score matching method will be conducted including (i) variables significantly different between the two cohorts in the bivariate descriptive analyses between the patient birth and the index event date (standard difference \< 0.10 ; appendix 1), and (ii) clinically relevant variables (known confusion factors linked to mortality and safety outcomes ; appendix 2) at the index event date. Variables related to patients will be described before and after propensity score matching.

You may qualify if:

  • Monobacterial methicillin susceptible Staphylococcus aureus (MSSa) bacteremia
  • In the cefazolin group : Cefazolin injectable prescription in the week before or the week after MSSa bacteremia
  • In the ASPs group :ASPs injectable prescription (flucloxacillin, floxacillin, cloxacillin, oxacillin, nafcillin and dicloxacillin) in the week before or the week after MSSa bacteremia

You may not qualify if:

  • In the cefazolin group : ASP injectable prescription in the year before or the year after MSSa bacteremia
  • In the ASPs group : cefazolin injectable prescription in the year before or the year after MSSa bacteremia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InfectionsBacteremia

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor (MD PhD)

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 22, 2025

Study Start

January 1, 2000

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Data are available upon reasonable request. Researchers can request access to data from the TriNetX research network through the TriNetX platform (https://live.trinetx.com). However, this may involve associated costs, require a data-sharing agreement and no patient-identifiable information can be accessible.