inezolid or vancomycin surgical site infection prophylaxisLOVip
- Conditions
- surgical antibiotic prophylaxisTherapeutic area: Not possible to specify
- Registration Number
- CTIS2023-504986-22-00
- Lead Sponsor
- Assistance Publique Hopitaux De Marseille
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1160
•Adult (=18 years) patients undergoing any elective surgery for which vancomycin is recommended in the guidelines as an alternative to beta-lactams, from different specialties including: neurological, cardiac, orthopedic, vascular, urology, ENT, maxillo-facial or digestive . It is possible to include patients undergoing a re-intervention, if it is not due to a suspected or proven infection., •Known allergy to beta-lactams AND/OR suspected or proven MRSA colonization. Proven MRSA colonization is defined as a positive patient sample within 3 months prior to surgery. Suspected MRSA colonization is defined when the patient has received antibiotic treatment within 3 months prior to surgery or is undergoing re-intervention more than 5 days after the first surgery., •Signed informed consent, •Patient affiliated to a social security system or equivalent.
•Surgery for suspected or proven SSI 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 1.73 m2, •Known allergy to linezolid or vancomycin or one of the excipients in their respective composition, •Hematologic malignancy, •Declared pregnancy or breastfeeding, •Patient under legal protection regime for adults, •Patient already enrolled in LOVip study for a previous surgery, •Patient with limited French proficiency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method