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Linezolid or Vancomycin Surgical Site Infection Prophylaxis

NCT05571722 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1160

Last updated 2026-02-05

No results posted yet for this study

Summary

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

  • Antibiotic Prophylaxis
  • General Surgery

Interventions

DRUG

Vancomycin Injection

Patients receive a dose of 30 mg/kg of vancomycin (2 hours infusion) starting 2.5 hours before the scheduled time of surgical incision as defined in the French guidelines.

DRUG

Linezolid Injection

Patients receive a dose of 1200 mg of linezolid (30 minutes infusion) 30 minutes before the scheduled time of surgical incision.

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • François CREMIEUX · Assistance Publique Hopitaux De Marseille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2028-12-03
Completion
2029-12-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05571722 on ClinicalTrials.gov