BridgeMD
Linezolid or vancomycin surgical site infection prophylaxis LOVip
EU CTIS ID: 2023-504986-22-00
What this study is testing
To demonstrate the non-inferiority of linezolid versus vancomycin as surgical antibiotic prophylaxis for all types of surgery in term of SSIs prevention at day-30 after surgery.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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.
You likely can't join if
- • 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
- • Patient with a history of hematologic malignancy or with ongoing hematologic malignancy
- • Declared pregnancy or breastfeeding
See the full eligibility criteria
- • 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
- • Patient with a history of hematologic malignancy or with ongoing 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.