Non-inferiority Trial Comparing Cloxacillin vs Cefazolin in Methicillin-susceptible Staphylococcus Aureus Bacteremia
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
"Methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia remains a major cause of
community- or hospital-acquired bloodstream infections with an overall mortality estimated
around 25%. Anti-staphylococcal penicillins (APs) such as oxacillin or cloxacillin are
recommended as first-line agents. With the exception of first-generation cephalosporin (1GC)
such as cefazolin, no alternative has yet proven a similar efficacy. Due to an unfavourable
safety profile for high doses used in severe infection, an uneasy dosing schedule in patients
with renal failure and possible recurrent stock-out events for APs, alternative to APs are
needed. This led to propose an open-label, randomized, controlled parallel groups, phase IV,
non-inferiority trial comparing the efficacy, the safety, and the ecological impact of
cefazolin versus cloxacillin for the treatment of MSSA bacteremia in adults.
The primary objective is to compare the therapeutic efficacy of cefazolin vs cloxacillin at
day 90 after the inclusion. "