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 study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Ca Aumxddcodg Argenteuil France
Cgwcih Hnsdfaduqwb Ulfnygqgphygy Dx Difad Dijon France
Baunscrl Urrrlmvrbw Hoevfnue Cksotv Besançon France
Cipd Da Ngmgl Vandoeuvre Les Nancy France
Inyzrytf dw Cvptbrayccpv Hiikctxscup Umaywcfxtoiwg ds Slcmj Eekdzpu (iunxgpb Saint Priest En Jarez France
Hiazjcji Umglrkxenyghid Sarkbixvme &uxmjgy Hfkufke dh Hquctojpacc STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
06.01.2020

Trial locations

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.

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 ID:
2024-516266-11-00
Protocol code:
PI2018_843_0007
NCT ID:
NCT03580733
Trial Phase:
Therapeutic confirmatory (Phase III)

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