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SAFE study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515398-90-01
Enrollment
300
Registered
2024-08-14
Start date
2020-08-17
Completion date
Unknown
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Staphylococcus aureus bacteremia

Brief summary

The primary outcome is success of therapy, defined at 180 days after randomization by presence of the following: 1. Patient alive. 2. No evidence of microbiologically confirmed disease relapse, defined as symptoms and/or signs of infection, after initial clinical improvement, with S. aureus isolated from blood or another normally sterile site (e.g. joint fluid, tissue) by conventional culture.

Interventions

DRUGCEFAZOLINE LDP-LABORATORIOS TORLAN 2 g
DRUGpoudre pour solution injectable/pour perfusion
DRUGFlucloxacillin 250mg Powder for Solution for Injection or Infusion
DRUGhard

Sponsors

Stichting Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary outcome is success of therapy, defined at 180 days after randomization by presence of the following: 1. Patient alive. 2. No evidence of microbiologically confirmed disease relapse, defined as symptoms and/or signs of infection, after initial clinical improvement, with S. aureus isolated from blood or another normally sterile site (e.g. joint fluid, tissue) by conventional culture.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026