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Study of Clindamycin Use During Heart Surgery with Extracorporeal Circulation to Prevent Surgical Site Infections

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What is this trial about?

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

The study investigates the use of clindamycin in patients who undergo cardiac surgery with extracorporeal circulation (a procedure where a machine temporarily takes over the function of the heart and lungs during surgery). The purpose is to determine if clindamycin can be used effectively instead of another antibiotic called vancomycin during heart surgery involving the aorta (the main blood vessel leaving the heart).

During the surgery, patients will receive clindamycin through a vein (intravenous administration). The medication will be given before the surgery begins and may be repeated if the operation lasts longer than 4 hours. The total daily amount of clindamycin will not exceed 1500 mg. Blood samples will be taken throughout the surgery to measure the amount of medication in the blood.

The study will also examine how the medication spreads in body tissues, particularly in the tissue around the heart. Researchers will monitor patients for three months after surgery to check for complications, including mediastinitis (a serious infection in the chest area between the lungs). They will also track how the body processes the medication and check for any unwanted effects.

The research process

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

  1. Step 1

    Initial medication administration

    You will receive clindamycin through an intravenous line before the heart surgery

    The medication will be given while you are prepared for the procedure with heart-lung bypass machine (also called extracorporeal circulation or ECC)

  2. Step 2

    Blood sampling during surgery

    Blood samples will be taken at the beginning of surgery

    Additional blood samples will be collected every hour during the procedure

    If the surgery lasts longer than 4 hours, you will receive another dose of clindamycin

    After any additional dose, blood samples will be taken immediately and then hourly until the end of surgery

  3. Step 3

    Post-surgery monitoring - 6 hours

    Blood tests will be performed 6 hours after surgery to check your liver and kidney function

    Your protein levels will also be measured at this time

  4. Step 4

    Post-surgery monitoring - 24 hours

    Additional blood tests will be performed 24 hours after surgery

    These tests will check your liver and kidney function

  5. Step 5

    Hospital stay monitoring

    Your health status will be monitored until you leave the hospital

    Any unusual reactions or side effects will be recorded

  6. Step 6

    Follow-up period

    Your recovery will be monitored for 3 months after surgery

    The medical team will check for any signs of chest infection

    A final check of your health status will be conducted by phone at the end of the 3-month period

Who can join the trial?

9 criteria

  • Age 18 years or older
  • Scheduled for heart surgery that requires a heart-lung machine (extracorporeal circulation)
  • Surgery must be scheduled for morning hours (starting at 8 AM) and planned at least 24 hours in advance
  • Must provide written informed consent before the study begins
  • Must be able to understand and speak French fluently
  • For women who can become pregnant: must have a negative pregnancy test and use effective birth control during the study
  • For men who can father children: must use effective birth control during the study
  • Must have social security coverage
  • Must be able to understand the study goals and follow all study requirements

Who cannot join the trial?

12 criteria

  • Known allergy or hypersensitivity to clindamycin or other similar antibiotics
  • Severe liver disease (conditions affecting proper liver function)
  • Severe kidney disease (conditions affecting proper kidney function)
  • Current infection requiring antibiotic treatment
  • Pregnancy or breastfeeding
  • History of severe gastrointestinal conditions like inflammatory bowel disease or colitis (inflammation of the intestines)
  • Participation in another clinical trial within the past 30 days
  • Any condition that, in the opinion of the medical team, could interfere with the study procedures
  • Inability to provide informed consent
  • History of adverse reactions to medications similar to clindamycin
  • Severe heart rhythm disorders that are not related to the planned surgery
  • Uncontrolled medical conditions that could affect surgery outcome
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Investigated drugs

  • Clindamycin

    is an antibiotic medication used to treat various bacterial infections. In this trial, it is being studied as a potential alternative to vancomycin during heart surgery. The medication works by stopping bacteria from growing and multiplying. It is particularly effective against many types of bacteria that can cause infections during cardiac procedures.

  • Vancomycin

    is a powerful antibiotic medication commonly used during heart surgeries to prevent infections. It is considered a standard treatment for preventing bacterial infections, particularly in patients undergoing cardiac surgery with extracorporeal circulation. This medication fights against serious bacterial infections and is especially effective against certain types of resistant bacteria.

What is already known about the treatment

  • Clindamycin

    A lincosamide antibiotic typically administered intravenously during surgical procedures, particularly effective in cardiac surgeries with extracorporeal circulation (ECC). This medication works by binding to bacterial ribosomes and preventing protein synthesis, making it effective against many gram-positive bacteria commonly associated with surgical site infections and mediastinitis. It serves as a potential alternative to vancomycin in cardiac surgery prophylaxis, with the advantage of good tissue penetration and a well-established safety profile. Clindamycin belongs to the class of lincosamide antibiotics and is particularly valued for maintaining therapeutic concentrations in blood during complex surgical procedures.

  • Vancomycin

    A glycopeptide antibiotic administered intravenously that serves as a standard prophylactic treatment in cardiac surgery with extracorporeal circulation. This medication prevents bacterial cell wall synthesis by binding to peptidoglycan precursors, making it highly effective against gram-positive bacteria, particularly those resistant to other antibiotics. It has been the gold standard for surgical prophylaxis in cardiac procedures, especially for preventing post-operative infections like mediastinitis. Vancomycin belongs to the glycopeptide antibiotic class and is known for its reliable effectiveness in maintaining therapeutic levels during surgery.

Investigated diseases

  • Mediastinitis

    A serious infection that occurs in the mediastinum, which is the space between the lungs containing the heart, large blood vessels, windpipe, esophagus, and other important structures. It can develop as a complication after cardiac surgery, particularly when using extracorporeal circulation. The condition involves inflammation and infection of the connective tissues that surround these vital organs. The infection can spread through the deep tissue spaces of the mediastinum, causing swelling and the formation of infected fluid collections.

  • Cardiac Surgery with Extracorporeal Circulation

    A surgical procedure where the heart's function is temporarily taken over by a heart-lung machine (extracorporeal circulation). During this procedure, the blood is diverted outside the body through special tubes, where it is oxygenated by the machine before being pumped back into the body. This allows surgeons to operate on a still, bloodless heart while maintaining circulation to the rest of the body. The process involves cooling the body temperature and using special solutions to protect the heart during surgery.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521555-23-00Protocol codeRC24_0549Estimated enrolment30 patientsSponsorCentre Hospitalier Universitaire De Nantes

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