Comparing Linezolid and Vancomycin for Preventing Surgical Site Infections

Linezolid or Vancomycin Surgical Site Infection Prophylaxis

This study tests whether the antibiotics Linezolid or Vancomycin can better prevent infections after surgery in patients who can't take certain other antibiotics.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 1160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (other)
• Locations: 1 site (Marseille)
• Trial ID: NCT05571722 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of two antibiotics, Linezolid and Vancomycin, in preventing surgical site infections (SSIs) in patients undergoing elective surgeries where beta-lactam antibiotics are not suitable. The study focuses on patients with known allergies to beta-lactams or those at risk for methicillin-resistant Staphylococcus aureus (MRSA) infections. By administering these antibiotics within 24 hours of surgery, the trial aims to determine which antibiotic is more effective in reducing the incidence of SSIs. The outcomes will be assessed by measuring SSI rates and identifying the microorganisms responsible for any infections that occur post-surgery.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older undergoing elective surgeries where Vancomycin is recommended due to beta-lactam allergies or suspected/proven MRSA colonization.

Not a fit: Patients who do not have a history of beta-lactam allergies or MRSA colonization may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved antibiotic prophylaxis protocols, reducing the incidence of surgical site infections and associated complications.

How similar studies have performed: Previous studies have shown varying success with antibiotic prophylaxis in surgical settings, but this specific comparison of Linezolid and Vancomycin is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Patients undergoing any elective surgery for which vancomycin is recommended in the guidelines as an alternative to beta-lactams including: neurosurgery, cardiac surgery, orthopedic surgery, vascular surgery, penile and testicular surgery, gastric banding procedure in digestive surgery.

This inclusion criteria can lead to the inclusion of patients who undergo a re-intervention provided that the re-intervention is not due to a suspected or proven infection and that the patient was not included in LOVip at the time of his/her first intervention;

* Age ≥ 18 years-old;
* Known allergy to beta-lactams AND/OR suspected or proven MRSA colonization. Proven MRSA colonization is defined as a positive patient sample (any type of swab or biological fluid) for MRSA within 3 months prior to surgery. MRSA colonization is suspected when the patient undergoing surgery has received antibiotic treatment within 3 months prior to surgery or is undergoing re-intervention more than 5 days after the first surgery. MRSA is defined as a strain of Staphylococcus aureus resistant to oxacillin or cefoxitin, predicting non-susceptibility to all classes of beta-lactam antimicrobials (except anti-MRSA cephalosporins) (6). In contrast, MSSA is defined as an oxacillin sensitive strain of Staphylococcus aureus;
* Informed consent of the patient;
* Affiliated to a social security system or equivalent.

Exclusion Criteria:

* Surgery for suspected or proven SSI (definition of SSI provided on chapter 3.6.1 Primary endpoint as defined by (5, 7)) according to international definitions;
* Obesity defined by a body mass index (BMI) \> 35 kg/m2 or a body weight \> 100 kg;
* Chronic kidney disease defined as glomerular filtration rate (GFR) \< 60 ml/min per 1.73m2;
* Known allergy to linezolid or vancomycin;
* Hematologic malignancy;
* Declared pregnancy or breastfeeding;
* Patient under legal protection regime for adults;
* Patient denying consent;
* Patient already included in LOVip for a previous surgery.

Where this trial is running

Marseille

• Anesthésie Réanimation - Hôpital Nord (AP-HM) — Marseille, France (RECRUITING)

Study contacts

• Study coordinator: Marc Leone, MD

Conditions: Antibiotic Prophylaxis, General Surgery