Linezolid or Vancomycin Surgical Site Infection Prophylaxis

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Oct 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether the antibiotic linezolid can be a better option than vancomycin for preventing infections in patients who are allergic to certain antibiotics or are at risk for a specific type of resistant bacteria called MRSA during elective surgeries. The researchers want to see if linezolid can effectively reduce the risk of surgical site infections, which can occur after operations, especially in patients who cannot take traditional antibiotics.

To be eligible for the trial, participants need to be at least 18 years old and scheduled for certain types of elective surgeries where vancomycin is typically recommended. They must have a known allergy to certain antibiotics or be suspected of carrying MRSA. Participants will receive either linezolid or vancomycin during their surgery and will be monitored for any signs of infection afterward. This trial is important as it could help improve antibiotic choices for patients who might be at higher risk for infections, ultimately leading to safer surgical outcomes.

Gender

ALL

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.