Non-inferiority Trial Comparing Cloxacillin vs Cefazolin in Methicillin-susceptible Staphylococcus Aureus Bacteremia

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 11, 2017

Keywords

ClinConnect Summary

This clinical trial is comparing two antibiotics, cloxacillin and cefazolin, to see which one works better for treating a serious blood infection caused by a bacteria called methicillin-susceptible Staphylococcus aureus (MSSA). The goal is to find out if cefazolin can be just as effective as cloxacillin, especially since cloxacillin can have some drawbacks, like needing careful dosing for patients with kidney issues. The study is open to adults over 18 who have a positive blood culture for MSSA and who meet certain health criteria.

If someone participates in this trial, they will receive either cloxacillin or cefazolin and will be monitored for 90 days to track how well the treatment works and if there are any side effects. It’s important to know that certain individuals, such as those with severe allergic reactions to specific antibiotics or those who are pregnant or breastfeeding, cannot take part in this study. Overall, this trial aims to provide more options for treating infections that can be life-threatening, with the hope of improving outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age above 18 years
• • 2. Blood culture positive to MSSA identified by standard bacteriologic techniques or by GeneXpert PCR
• Exclusion Criteria:
• • 1. Previous type 1 or grade 3 - 4 according to CTCAE hypersensitivity reaction to beta-lactams
• • 2. Known pregnancy or breastfeeding women
• • 3. Parenteral antimicrobial therapy active against MSSA for more than 72 hours after the positive SA blood culture ponction
• • 4. Chronic renal failure defined by a glomerular filtration rate estimated \< 30 mL/min/1,73m².
• • 5. Presence of an intra-vascular implant (vascular or valvular prosthesis or cardiovascular implantable electronic device)
• • 6. Patient with implanted material considered to be infected by SAMS and whose antibiotic treatment is longer than 70 days
• • 7. New cerebro-spinal signs in the preceding month
• • 8. Clinical examination compatible with recent stroke (\<1 month), brain abscess or meningitis
• • 9. Current other antibiotic therapy which cannot be ceased or substituted by study treatment
• • 10. Mixed blood culture with more than one pathogen (excluding contaminants: Corynebacterium sp., Propionibacterium sp., Coagulase-Negative Staphylococci)
• • 11. coagulapthy with TP\< 50% (excepted for patients under avk anticoagulant treatment)
• • 12. Absence of written informed consent from the patient
• • 13. Limitation of care with expected life duration below 90 days
• • 14. Patient under guardianship or trusteeship
• • 15. No affiliation to social security (beneficiary or assignee)
• • 16. Subject already involved in another interventional clinical research evaluating a medicinal product
• Secondary exclusion criteria:
• • 1. Diagnosis of meningitis made after randomisation
• • 2. Diagnosis of brain abscess made after randomisation
• • 3. Diagnosis of multiple infection made after randomisation