Recruiting

Study on Linezolid and Vancomycin for Preventing Surgical Site Infections in Patients Undergoing Surgery

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on preventing infections that can occur after surgery, known as surgical site infections. The study is examining the effectiveness of two antibiotics, linezolid and vancomycin, in preventing these infections. Linezolid is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein. Vancomycin is also given as a solution for infusion and is used in various forms, including vancomycin hydrochloride.

The purpose of the study is to determine if linezolid is as effective as vancomycin in preventing surgical site infections within 30 days after surgery. Participants in the study will receive either linezolid or vancomycin as part of their surgical care. The study will monitor the participants for any signs of infection after their surgery to compare the effectiveness of the two antibiotics.

The study will involve adult patients who are undergoing elective surgeries, which are planned surgeries that are not emergencies. These surgeries can be from various medical specialties, such as neurological, cardiac, orthopedic, and others. The study aims to provide valuable information on the best antibiotic choice for preventing infections in patients who cannot use certain other antibiotics due to allergies or specific bacterial colonization.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the clinical trial, you will be required to sign an informed consent form. This document confirms your understanding of the trial and your agreement to participate.
You must be an adult aged 18 or older, undergoing elective surgery where vancomycin is recommended as an alternative to beta-lactams. This includes surgeries in various specialties such as neurological, cardiac, orthopedic, and others.
Step 2
Eligibility confirmation
Your eligibility will be confirmed based on criteria such as known allergy to beta-lactams or suspected/proven MRSA colonization. MRSA colonization is determined by a positive sample within 3 months prior to surgery or recent antibiotic treatment.
Step 3
Pre-surgery preparation
Before your surgery, you will receive either linezolid or vancomycin as a preventive measure against surgical site infections.
Linezolid will be administered at a dose of 1200 mg, while vancomycin will be given at 30 mg per kg of body weight. Both medications are provided through an infusion, which is a method of delivering medication directly into your bloodstream.
Step 4
Surgery and immediate recovery
During your surgery, the medication will help prevent infections at the surgical site. Your medical team will monitor your condition closely.
Step 5
Post-surgery follow-up
After surgery, you will be monitored for any signs of infection for up to 30 days. This is to ensure the effectiveness of the medication in preventing surgical site infections.
Regular check-ups may be scheduled to assess your recovery and address any concerns you might have.
Step 6
Completion of trial participation
Your participation in the trial will conclude after the 30-day post-surgery monitoring period. At this point, your involvement in the study is complete.

Who can join the trial?

4 criteria

Patients must be 18 years or older and undergoing planned surgery where the use of vancomycin is recommended as an alternative to beta-lactam antibiotics. This includes surgeries in areas like the brain, heart, bones, blood vessels, urinary system, ear, nose, throat, face, or digestive system. Patients having a second surgery can also participate if it is not due to an infection.
Patients must have a known allergy to beta-lactam antibiotics or be suspected or proven to have MRSA colonization. MRSA is a type of bacteria that is resistant to many antibiotics. Proven MRSA colonization means a positive test result within 3 months before surgery. Suspected MRSA colonization means the patient has taken antibiotics within 3 months before surgery or is having a second surgery more than 5 days after the first one.
Patients must have signed an informed consent, which means they understand the study and agree to participate.
Patients must be affiliated with a social security system or have equivalent coverage.

Who cannot join the trial?

7 criteria

Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have any medical condition that the study does not cover.
Patients who are not eligible for the specific type of surgery being studied.
Patients who have allergies or adverse reactions to the medications being tested, such as linezolid or vancomycin.
Patients who are currently participating in another clinical trial.
Patients who are unable to follow the study procedures or attend follow-up visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Assistance Publique Hopitaux De Paris
Paris, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Linezolid
is an antibiotic used to prevent infections that can occur after surgery. It works by stopping the growth of bacteria, which helps to prevent surgical site infections. In this trial, linezolid is being tested to see if it is as effective as another antibiotic in preventing infections after surgery.
Vancomycin
is another antibiotic used to prevent infections after surgery. It is commonly used to treat serious bacterial infections and works by killing bacteria or preventing their growth. In this trial, vancomycin is being compared to linezolid to see which one is better at preventing surgical site infections.

What is already known about the treatment

Linezolid
Linezolid is administered orally or intravenously and is currently being studied for its effectiveness in preventing infections at surgical sites. It is recognized in medical literature as a potential alternative to vancomycin for this purpose. The main use of linezolid in this context is to prevent infections after surgery. At the molecular level, linezolid works by stopping bacteria from making proteins they need to grow, which helps prevent infections. It is classified as an antibiotic, specifically a type of oxazolidinone.
Vancomycin
Vancomycin is administered intravenously and is a well-established medication in the medical field, often used to prevent infections at surgical sites. It is being compared to linezolid in clinical trials to determine its effectiveness in preventing infections after surgery. Vancomycin works by interfering with the bacteria's cell wall formation, which is essential for their survival, thus preventing infections. It is classified as an antibiotic, specifically a glycopeptide.

Investigated diseases

Surgical Site Infections (SSIs) – Surgical Site Infections are infections that occur after surgery in the part of the body where the surgery took place. They can involve the skin, tissues under the skin, organs, or implanted material. SSIs typically develop within 30 days after the operation and can cause redness, pain, and swelling at the site of the surgery. In some cases, they may lead to the discharge of pus or other fluids. The progression of SSIs can vary, with some infections remaining localized and others spreading to deeper tissues or the bloodstream. The severity and progression depend on factors such as the type of surgery, the patient's health, and the presence of any underlying conditions.