New antibiotic may outperform standard care in preventing surgical infections
NCT ID NCT05571722
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether linezolid works better than vancomycin at preventing surgical site infections in people having elective surgery who are allergic to common antibiotics or at risk for MRSA. About 1,160 adults will be randomly assigned to receive one of the two antibiotics before their operation. The goal is to see which drug leads to fewer infections within the first year after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anesthésie Réanimation - Hôpital Nord (AP-HM)
RECRUITINGMarseille, 13015, France
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