RecruitingPhase 4NCT05571722

Linezolid or Vancomycin Surgical Site Infection Prophylaxis


Sponsor

Assistance Publique Hopitaux De Marseille

Enrollment

1,160 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called LOVip) compares two antibiotics — linezolid and vancomycin — used before surgery to prevent infections at the wound site in patients who cannot receive standard beta-lactam antibiotics. These patients are either allergic to beta-lactams or are at risk of carrying MRSA (a drug-resistant staph infection). The study covers several types of surgery including brain, heart, orthopedic, vascular, and digestive procedures. You may be eligible if: - You are 18 years of age or older - You are scheduled for an elective surgery that calls for vancomycin as a preventive antibiotic (per guidelines) - You have a known allergy to beta-lactam antibiotics AND/OR are suspected or confirmed to carry MRSA - You are affiliated with a social security system You may NOT be eligible if: - Your surgery is for a suspected or confirmed existing wound infection - Your BMI is above 35 or your weight is above 100 kg - You have chronic kidney disease (GFR below 60) - You have a known allergy to linezolid or vancomycin - You have a blood cancer (hematological malignancy) - You are pregnant or breastfeeding - You are under legal adult protection - You have already been included in the LOVip trial for a previous surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVancomycin 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.

DRUGLinezolid Injection

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


Locations(1)

Anesthésie Réanimation - Hôpital Nord (AP-HM)

Marseille, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05571722


Related Trials