Non-inferiority Trial Comparing Cloxacillin vs Cefazolin in Methicillin-susceptible Staphylococcu… (NCT03248063) | Clinical Trial Compass
CompletedNot Applicable
Non-inferiority Trial Comparing Cloxacillin vs Cefazolin in Methicillin-susceptible Staphylococcus Aureus Bacteremia
France315 participantsStarted 2018-09-05
Plain-language 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. "
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Age above 18 years
âś“. Blood culture positive to MSSA identified by standard bacteriologic techniques or by GeneXpert PCR
Exclusion criteria
âś•. Previous type 1 or grade 3 - 4 according to CTCAE hypersensitivity reaction to beta-lactams
âś•. Known pregnancy or breastfeeding women
âś•. 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.
âś•. Presence of an intra-vascular implant (vascular or valvular prosthesis or cardiovascular implantable electronic device)
âś•. Patient with implanted material considered to be infected by SAMS and whose antibiotic treatment is longer than 70 days
âś•. New cerebro-spinal signs in the preceding month
What they're measuring
1
Therapeutic efficacy
Timeframe: 90 days after beginning of antibiotic treatment