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Study of the distribution of cefazolin in the chest area of children undergoing heart surgery to prevent infection.

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 study aims to describe how the antibiotic cefazolin moves through the mediastinum, which is the area in the middle of the chest between the lungs, in children after heart surgery. The research focuses on infection prophylaxis, which is a way to prevent infections from occurring before they start. During the study, cefazolin is given through intravenous administration, meaning it is delivered directly into a vein.

The process involves using microdialysis, a method used to monitor the levels of a substance in the body's tissues. Participants will have their levels monitored to see how the medication travels from the blood into the chest area. Researchers will also monitor signs of inflammation, such as CRP, which is a protein in the blood that increases when there is irritation or infection in the body, and watch for any signs of mediastinitis, an infection in the middle of the chest.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    After cardiac surgery, a medication called cefazolin is given to prevent infections. this medicine is administered through an intravenous line, which means it is delivered directly into a vein.

    The amount of cefazolin provided is 75 mg/kg (75 milligrams for every kilogram of body weight).

  2. Step 2

    Monitoring and data collection

    A small device called a microdialysis probe is used to measure how the cefazolin is distributed in the mediastinum, which is the area in the middle of the chest between the lungs.

    Information regarding clinical progression, such as survival or the presence of new infections, is recorded.

    Levels of inflammation markers, specifically CRP (a substance in the blood that indicates inflammation), are monitored.

  3. Step 3

    Follow-up period

    Data collection continues for one month following the removal of the microdialysis probe.

    During this time, any antibiotics received and the presence of any bacterial infections are documented.

Who can join the trial?

9 criteria

  • The patient must be a child between 3 months and 2 years old.
  • The child must be staying in a special hospital unit for children after heart surgery, known as a paediatric cardiac surgical intensive care unit.
  • The child must have been treated for a congenital heart disease, which is a heart condition that a baby is born with.
  • The specific heart conditions included are ventricular septal defect (VSD), which is a hole between the lower chambers of the heart; atrial septal defect (ASD), which is a hole between the upper chambers of the heart; pulmonary stenosis, which is a narrowing of the valve that lets blood flow to the lungs; or tetralogy of Fallot, which is a combination of four different heart defects.
  • The surgery must involve a sternotomy, which means the surgeon makes an opening through the breastbone to reach the heart.
  • The surgery must use intraoperative cardiopulmonary bypass, which is a machine that takes over the job of the heart and lungs during the operation.
  • The child must have received cefazolin, which is an antibiotic prophylaxis, meaning a medicine given before surgery to prevent an infection.
  • The patient must have social security coverage, which is a form of health insurance.
  • The legal guardians, or the people legally responsible for the child, must understand the study information and sign a consent form to agree to participate.

Who cannot join the trial?

11 criteria

  • You are scheduled for emergency cardiac surgery, which means a heart operation that must be done immediately due to a life-threatening situation.
  • A relative of yours is the investigator, which is the doctor or researcher in charge of enrolling people into this study.
  • You have a history of cardiac or thoracic surgery, meaning you have had operations on your heart or the chest area in the past.
  • You have haemostasis disorders, which are conditions that prevent your blood from clotting properly to stop bleeding.
  • You have immunodeficiency, which means your body's immune system (the system that fights germs) is not working correctly.
  • You have bacterial colonization, which means germs are living in your body, and you are being given a type of preventative medicine other than cefazolin.
  • You have hypersensitivity, which is an allergic reaction, to the medicine being studied, or to cephalosporin or penicillin antibiotics.
  • You are already participating in another interventional study, which is a clinical trial where researchers give a specific treatment to see how it works.
  • You have already joined this specific study.
  • You have a medical reason why you cannot undergo microdialysis (a method used to measure medicine levels in body fluids) or surgery.
  • You are taking another medicine that might interfere with how cefazolin works, or you have taken cefazolin in the last 7 days.
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Investigated drugs

Cefazolin is an antibiotic medication given through a vein to help fight and prevent bacterial infections.

What is already known about the treatment

Cefazolin - This medication is an antibiotic that is given directly into a vein through an intravenous injection. It is a well-established treatment used to prevent and fight various bacterial infections. It works by preventing bacteria from building their protective cell walls, which causes them to break apart and die. This drug belongs to a group of medicines known as first-generation cephalosporins.

Investigated diseases

Mediastinitis - This is an inflammation or infection located in the mediastinum, which is the area in the middle of the chest between the lungs. It often develops following surgery or other invasive procedures in the chest area. The condition typically begins when bacteria enter this space and begin to multiply. As it progresses, the inflammation can spread to nearby tissues and organs within the chest cavity. It is characterized by an increase in inflammatory markers in the body.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-521988-13-00Protocol codeAPHP241591Estimated enrolment10 patientsSponsorAssistance Publique Hopitaux De Paris

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