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Study on Intraperitoneal Treatment with Fosfomycin, Metronidazole, and Molgramostim for Patients with Multi-Quadrant Peritonitis Undergoing Abdominal Surgery

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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 studying the treatment of peritonitis, a serious infection of the lining of the abdominal cavity. The study will explore the effectiveness of three medications: fosfomycin, metronidazole, and a substance known as recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). These medications will be administered directly into the abdominal area to see if they can improve treatment outcomes for patients undergoing surgery for this condition.

The purpose of the study is to determine if this combination of medications can optimize the treatment of patients with multiquadrant peritonitis, which means the infection affects multiple areas of the abdomen. Participants in the study will receive either the medication combination or a placebo. The study will monitor changes in certain biological markers and overall recovery to assess the effectiveness of the treatment.

Throughout the study, participants will undergo regular assessments to track their progress and any changes in their condition. The trial aims to provide valuable insights into improving treatment strategies for those affected by this challenging condition. The study is expected to continue until 2030, with recruitment starting in 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will be asked to provide consent to participate.

    Eligibility is based on being 18 years or older and undergoing surgery for peritonitis affecting at least two quadrants of the abdomen.

  2. Step 2

    Surgical intervention

    During your scheduled surgery, the medical team will assess the extent of peritonitis.

    This step is crucial for determining the appropriate treatment plan within the trial.

  3. Step 3

    Treatment administration

    You will receive an intraperitoneal infusion, which means the medication is delivered directly into the abdominal cavity.

    The medications used include metronidazole, molgramostim (a form of GM-CSF), fosfomycin, and a saline solution.

    The exact dosage and frequency will be determined by the medical team based on your specific condition.

  4. Step 4

    Monitoring and follow-up

    After treatment, your recovery and response to the medication will be closely monitored.

    This includes regular assessments of your health and any changes in your condition.

    Blood tests will be conducted to measure various markers, including cytokine levels and other blood values.

  5. Step 5

    Completion of trial participation

    Your participation in the trial will continue until the study's end date or until your medical team determines it is appropriate to conclude your involvement.

    The estimated end date for the trial is April 1, 2030.

Who can join the trial?

5 criteria

  • Patients must be 18 years or older.
  • Patients must be undergoing a surgical intervention (an operation) where they have been found to have peritonitis (an infection in the lining of the abdomen).
  • The peritonitis must be due to a problem in the large intestine (part of the digestive system).
  • The infection must involve two or more quadrants of the abdomen (the abdomen is divided into four areas, or quadrants).
  • Both male and female patients can participate.

Who cannot join the trial?

3 criteria

  • Patients who do not have peritonitis cannot participate. Peritonitis is an inflammation of the lining of the abdomen.
  • Patients who are not within the specified age range cannot participate. The age range includes both adults and children.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

  • Fosfomycin

    is an antibiotic used to treat infections caused by bacteria. In this trial, it is administered directly into the abdominal cavity to help fight the infection in patients with peritonitis, which is an inflammation of the inner lining of the abdomen. By delivering the medication directly to the site of infection, it aims to effectively reduce the bacterial load and improve the patient's condition.

  • Metronidazole

    is another antibiotic that is effective against certain types of bacteria and parasites. In this study, it is also given directly into the abdominal area to target and eliminate the bacteria causing the infection. This approach is intended to enhance the treatment of peritonitis by ensuring that the medication reaches the affected area quickly and efficiently.

  • Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)

    is a substance that helps stimulate the body's immune system. It encourages the production of white blood cells, which are crucial for fighting infections. In this trial, GM-CSF is used to boost the patient's immune response, helping their body to better combat the infection associated with peritonitis.

What is already known about the treatment

  • Fosfomycin

    Fosfomycin is administered directly into the abdominal cavity, a method known as intraperitoneal administration, to treat infections like peritonitis, which is an inflammation of the abdominal lining. Currently, fosfomycin is being studied in clinical trials to determine its effectiveness in treating multi-quadrant peritonitis, a severe form of the condition. It works by disrupting the formation of the bacterial cell wall, which is essential for bacterial survival, thereby killing the bacteria. Fosfomycin is classified as an antibiotic and is used primarily to combat bacterial infections.

  • Metronidazole

    Metronidazole is given intraperitoneally, meaning it is delivered directly into the abdominal cavity, to help treat peritonitis, an infection of the abdominal lining. It is currently being evaluated in clinical trials to assess its role in treating multi-quadrant peritonitis. Metronidazole works by entering the bacterial cells and disrupting their DNA, which prevents the bacteria from multiplying and leads to their death. It is classified as an antibiotic and is commonly used to treat infections caused by anaerobic bacteria and certain parasites.

  • Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)

    GM-CSF is administered intraperitoneally, which means it is injected directly into the abdominal cavity, to aid in the treatment of peritonitis, an inflammation of the abdominal lining. It is currently under investigation in clinical trials to determine its effectiveness in enhancing the treatment of multi-quadrant peritonitis. GM-CSF works by stimulating the production and function of white blood cells, which are crucial for fighting infections. It is classified as an immunostimulant, a type of medication that boosts the immune system's ability to combat infections.

Investigated diseases

Peritonitis – Peritonitis is an inflammation of the peritoneum, the thin layer of tissue that lines the inside of the abdomen and covers most of the abdominal organs. It typically occurs due to a bacterial or fungal infection, often resulting from a rupture in the abdominal wall or an infection spreading from another part of the body. The condition can cause severe abdominal pain, tenderness, and swelling, often accompanied by fever and nausea. As the inflammation progresses, it can lead to the accumulation of fluid in the abdominal cavity and a decrease in bowel movements. If not addressed, the inflammation can spread, affecting other organs and leading to more severe complications. The progression of peritonitis can vary depending on the underlying cause and the individual's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-520317-49-00Protocol code2025-GMF-1Estimated enrolment32 patientsSponsorRegion Sjaelland

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