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New treatment option for Antibiotic Prophylaxis
Official title Linezolid or Vancomycin Surgical Site Infection Prophylaxis
ClinicalTrials.gov ID: NCT05571722
What this study is testing
What is Vancomycin Injection?
Vancomycin Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for antibiotic prophylaxis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Anesthesia and surgical guidelines recommend the administration of a surgical antibiotic prophylaxis for patients undergoing "clean" surgery. The prescribed antibiotic should target the bacteria most commonly found in surgical site infections (SSIs) and the duration of administration should not exceed 24 hours to minimize the ecological risk of bacterial resistance emergence.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients undergoing any elective surgery for which vancomycin is recommended in the guidelines as an alternative to beta-lactams including...
- 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...
- Informed consent of the patient;
- Affiliated to a social security system or equivalent.
You likely can't join if
- 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...
- 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;
See the full eligibility 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...
- 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...
- Informed consent of the patient;
- Affiliated to a social security system or equivalent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.