Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05571722

Linezolid versus Vancomycin for Surgical Site Infection Prevention in Elective Surgeries

Led by Assistance Publique Hopitaux De Marseille · Updated on 2026-02-05

1160

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of linezolid compared to vancomycin as surgical antibiotic prophylaxis to prevent infections in patients undergoing clean elective surgeries. This study focuses on patients allergic to beta-lactams or at risk of infections caused by methicillin-resistant Staphylococcus aureus (MRSA). Surgical site infections can lead to longer hospital stays and increased costs, so finding effective antibiotic options is important for patient care and resistance prevention. The trial compares two groups: one receiving vancomycin at 30 mg/kg infused over 2 hours starting 2.5 hours before surgery, following French guidelines, and the other receiving a 1200 mg dose of linezolid infused over 30 minutes, administered 30 minutes before surgery. Both antibiotics are given intravenously and target Gram-positive bacteria including MRSA. The study includes various elective surgeries such as neurosurgery, cardiac, orthopedic, vascular, and digestive procedures. Participants will be monitored for infection rates 30 days and 365 days after surgery, treatment compliance, hospital stay durations, mortality rates, antibiotic-free days, and infection types. Researchers will also assess costs and quality of life scores during the study period. Safety and effectiveness of the antibiotics will be tracked through clinical evaluations and laboratory results, with participant follow-up lasting up to one year after surgery.

CONDITIONS

Brief Title

Linezolid or Vancomycin Surgical Site Infection Prophylaxis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective surgery where vancomycin is recommended as an alternative to beta-lactams, including neurosurgery, cardiac surgery, orthopedic surgery, vascular surgery, penile and testicular surgery, or gastric banding procedure
  • Patients undergoing re-intervention not related to infection and not previously included in the study
  • 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 to a social security system or equivalent
Not Eligible

You will not qualify if you...

  • Surgery for suspected or proven surgical site infection
  • Obesity with body mass index over 35 or weight above 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
  • Patient denies consent
  • Previously included in the LOVip study for prior surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 day

Participants receive a dose of either vancomycin or linezolid as surgical antibiotic prophylaxis before their elective surgery.

1 visit (in-person) on the day of surgery

Follow-up

Duration - 365 days

Participants are monitored for surgical site infections and other outcomes for up to 365 days after surgery.

Visits or assessments may occur up to day 365 after surgery

Trial Site Locations

Total: 1 location

1

Anesthésie Réanimation - Hôpital Nord (AP-HM)

Marseille, France, 13015

Actively Recruiting

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Research Team

M

Marc Leone, MD

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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Frequently Asked Questions

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