Actively Recruiting
Linezolid or Vancomycin Surgical Site Infection Prophylaxis
Led by Assistance Publique Hopitaux De Marseille · Updated on 2026-02-05
1160
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Anesthesia and surgical guidelines recommend the administration of a surgical antibiotic prophylaxis for patients undergoing "clean" surgery. The prescribed antibiotic should target the bacteria most commonly found in surgical site infections (SSIs) and the duration of administration should not exceed 24 hours to minimize the ecological risk of bacterial resistance emergence. Guidelines provide a framework for the administration of surgical antibiotic prophylaxis but their effectiveness is regularly re-evaluated by measuring the rates of SSIs and the microorganisms responsible for infectious complications after surgery. The majority of interventions required the use of first or second generation cephalosporins as surgical antibiotic prophylaxis. For patients with allergy to beta-lactams, clindamycin and vancomycin are proposed as alternatives. In the patients with methicillin-resistant S. aureus (MRSA) colonization or if those at risk of developing MRSA-associated SSI (hospital ecology, previous antibiotic treatment), only vancomycin is recommended. Vancomycin pharmacokinetics and pharmacodynamics is complex and its tissue absorption varies according to the level of tissue inflammation. This is a difficult molecule to handle, exclusively administered via intravenous route. Linezolid is a synthetic antibiotic from the oxazolidinone class. By binding to the rRNA on the 30S and 50S ribosomal subunits, it inhibits the bacterial synthesis. It is therefore a bacteriostatic antibiotic approved for the treatment of both methicillin susceptible S. aureus (MSSA) and MRSA infections. It also covers a broad spectrum of Gram positive bacteria. Its pharmacokinetics allows rapid intravenous infusion, with rapid penetration into bone and soft tissue of the surgical site during hip surgery. A large Cochrane meta-analysis reported that linezolid was superior to vancomycin in skin infections, including MRSA infections, albeit with low quality evidence. We therefore hypothesized that linezolid can be used instead of vancomycin for beta-lactam allergic patients and patients at risk of MRSA-associated SSI in general surgery.
CONDITIONS
Official Title
Linezolid or Vancomycin Surgical Site Infection Prophylaxis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing elective surgery where vancomycin is recommended as a beta-lactam alternative, including neurosurgery, cardiac, orthopedic, vascular, penile/testicular, and gastric banding surgeries
- Age 18 years or older
- Known allergy to beta-lactams and/or suspected or proven MRSA colonization within 3 months prior to surgery
- Informed consent given by the patient
- Affiliated with a social security system or equivalent
You will not qualify if you...
- Surgery for suspected or proven surgical site infection
- Body mass index over 35 kg/m2 or body weight over 100 kg
- Chronic kidney disease with glomerular filtration rate below 60 ml/min per 1.73m2
- Known allergy to linezolid or vancomycin
- Hematologic malignancy
- Pregnancy or breastfeeding
- Under legal protection regime for adults
- Denying consent
- Previously included in this trial for another surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Anesthésie Réanimation - Hôpital Nord (AP-HM)
Marseille, France, 13015
Actively Recruiting
Research Team
M
Marc Leone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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