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Study of caspofungin compared to placebo for treating yeast infections in the abdomen in intensive care unit patients

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What is this trial about?

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

This study focuses on treating yeast intra-abdominal infection, a type of infection that occurs inside the abdomen, and peritonitis, which is inflammation of the tissue lining the inner wall of the abdomen. The study compares two treatments: caspofungin, a medication given through an intravenous line, and a placebo. The purpose is to determine if caspofungin can reduce the rate of treatment failure in patients who are in intensive care units after surgery for abdominal infections.

The medication being tested, caspofungin (brand name Cancidas), is available in two different strengths: 50 mg and 70 mg. It comes as a powder that is mixed with sodium chloride solution to create a liquid that can be given through a vein. The treatment period lasts for up to 8 weeks, during which patients receive daily doses of either caspofungin or placebo.

During the study, doctors will monitor patients for 28 days after starting treatment to see how well the medication works. They will also track patients' progress for up to 90 days to gather additional information about the treatment's effectiveness and safety. The study uses a double-blind design, which means neither the patients nor their doctors know who is receiving caspofungin or placebo during the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment setup

    After admission to the intensive care unit (ICU) following surgery for abdominal infection, you will be evaluated for participation in the study.

    The medical team will assess your condition using a special scoring system called the Peritonitis score or check for the presence of yeast in samples taken during surgery.

  2. Step 2

    Treatment administration

    You will receive either caspofungin or a placebo through an intravenous line (directly into your vein).

    The medication comes in two possible strengths: 50 mg or 70 mg, prepared as a solution for infusion.

    A sterile salt solution (sodium chloride 0.9%) will be used to prepare the medication.

  3. Step 3

    Monitoring period - day 28

    Your condition will be closely monitored for 28 days after starting treatment.

    The medical team will assess your response to treatment and collect blood samples to measure levels of a substance called ß-D-glucan.

    Treatment success or failure will be evaluated at the end of this period.

  4. Step 4

    Extended follow-up - day 90

    Your health status will continue to be monitored until day 90.

    This extended monitoring helps evaluate the long-term outcomes of the treatment.

Who can join the trial?

6 criteria

  • Must be 18 years or older
  • Must have active health insurance coverage
  • Must be admitted to the Intensive Care Unit (ICU) after surgery for an infection inside the abdomen with either:
    • Suspected yeast infection in the abdomen (with a special score of 3 or higher), or
    • Confirmed yeast infection found in the abdominal fluid during surgery
    • Must be able to understand and sign an informed consent form agreeing to participate in the study
    • Both men and women can participate in the study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Known allergy or hypersensitivity to antifungal medications
  • Pregnant or breastfeeding women
  • Patients with severe liver disease (as measured by liver function tests)
  • Patients with severe kidney disease (as indicated by reduced kidney function)
  • Current participation in other clinical trials
  • History of organ transplantation
  • Patients with neutropenia (abnormally low levels of white blood cells)
  • Patients receiving immunosuppressive therapy (medications that lower immune system function)
  • Life-threatening conditions requiring intensive care
  • Inability to provide informed consent
  • Known drug or alcohol abuse within the past 6 months
  • History of non-compliance with medical treatments
  • Presence of other serious infections requiring additional antimicrobial therapy
  • Patients with severe heart conditions
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Investigated drugs

Caspofungin is an antifungal medication used to treat serious fungal infections. It works by preventing fungi from forming their cell walls properly, which helps stop the infection from spreading. This medication is specifically used to treat yeast infections in the abdominal area of patients in intensive care units. It is administered through an intravenous (IV) line directly into the bloodstream. Note: The study compares this medication to a placebo, but as requested, the placebo details are not included in this description.

What is already known about the treatment

Caspofungin – A modern antifungal medication administered intravenously that belongs to the echinocandin class of drugs, which works by disrupting the formation of fungal cell walls. This medication is primarily used to treat serious fungal infections, particularly in intensive care settings, with specific effectiveness against intra-abdominal yeast infections and peritonitis. Caspofungin acts by inhibiting the enzyme beta-(1,3)-D-glucan synthase, which is essential for fungal cell wall integrity, making it an important treatment option for critically ill patients who have developed invasive fungal infections.

Investigated diseases

  • Intra-abdominal Candidiasis

    A fungal infection in the abdominal cavity caused by Candida yeast species. The infection develops within the peritoneal space, which is the area between the organs in the abdomen. The condition typically begins when Candida yeast enters the abdominal cavity, often through a perforation or surgical procedure. The infection can spread throughout the abdomen, causing inflammation of the peritoneum (peritonitis). As the infection progresses, it can lead to the formation of abscesses and cause digestive symptoms.

  • Fungal Peritonitis

    An inflammatory condition of the peritoneum (the membrane lining the abdominal cavity) caused by fungal organisms. The infection affects the peritoneal membrane, causing it to become inflamed and irritated. Patients typically develop accumulation of fluid in the abdominal cavity. The condition can spread throughout the abdominal cavity, affecting multiple organs and tissues within this space.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516266-11-00Protocol codePI2018_843_0007Estimated enrolment448 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie

sourced from the EU Clinical Trials Register and site verification

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