Status:
COMPLETED
Non-inferiority Trial Comparing Cloxacillin vs Cefazolin in Methicillin-susceptible Staphylococcus Aureus Bacteremia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Bacteremia Due to Methicillin Susceptible Staphylococcus Aureus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-st...
Detailed Description
"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-st...
Eligibility Criteria
Inclusion
- Age above 18 years
- Blood culture positive to MSSA identified by standard bacteriologic techniques or by GeneXpert PCR
Exclusion
- Previous type 1 or grade 3 - 4 according to CTCAE hypersensitivity reaction to beta-lactams
- Known pregnancy or breastfeeding women
- Parenteral antimicrobial therapy active against MSSA for more than 72 hours after the positive SA blood culture ponction
- Chronic renal failure defined by a glomerular filtration rate estimated \< 30 mL/min/1,73m².
- Presence of an intra-vascular implant (vascular or valvular prosthesis or cardiovascular implantable electronic device)
- Patient with implanted material considered to be infected by SAMS and whose antibiotic treatment is longer than 70 days
- New cerebro-spinal signs in the preceding month
- Clinical examination compatible with recent stroke (\<1 month), brain abscess or meningitis
- Current other antibiotic therapy which cannot be ceased or substituted by study treatment
- Mixed blood culture with more than one pathogen (excluding contaminants: Corynebacterium sp., Propionibacterium sp., Coagulase-Negative Staphylococci)
- coagulapthy with TP\< 50% (excepted for patients under avk anticoagulant treatment)
- Absence of written informed consent from the patient
- Limitation of care with expected life duration below 90 days
- Patient under guardianship or trusteeship
- No affiliation to social security (beneficiary or assignee)
- Subject already involved in another interventional clinical research evaluating a medicinal product
- Secondary exclusion criteria:
- Diagnosis of meningitis made after randomisation
- Diagnosis of brain abscess made after randomisation
- Diagnosis of multiple infection made after randomisation
Key Trial Info
Start Date :
September 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2025
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT03248063
Start Date
September 5 2018
End Date
March 10 2025
Last Update
November 24 2025
Active Locations (1)
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1
François-Xavier Lescure
Paris, France, 75018