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Study of intraperitoneal fosfomycin, metronidazole and molgramostim treatment in patients with multi-quadrant peritonitis during abdominal surgery

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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 peritonitis, which is an inflammation of the tissue lining the inner wall of the abdomen and covering the abdominal organs. The study specifically looks at cases where the infection has spread to multiple areas of the abdomen. The purpose is to examine if delivering medications directly into the abdominal cavity can improve treatment outcomes for patients who need abdominal surgery.

The treatment being tested combines three medications: fosfomycin and metronidazole, which are antibiotics that fight bacterial infections, and molgramostim (also called Repomol), which is a substance that helps boost the body's immune system. These medications will be given directly into the abdominal cavity during surgery. Some patients will receive these medications, while others will receive a placebo with sodium chloride solution.

During the study, doctors will collect fluid samples from the abdominal cavity and blood samples to measure how well the treatment is working. They will also monitor patients' recovery after surgery. The treatment will be given as a single dose during the surgical procedure, and patients will be followed to evaluate their healing process.

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 surgical procedure

    During surgery for peritonitis (infection of the abdominal cavity lining), you will receive treatment for an intestinal condition affecting multiple areas of your abdomen.

    The surgical procedure will address the underlying cause of the infection in your large intestine.

  2. Step 2

    Medication administration

    You will receive three medications directly into your abdominal cavity:

    - Fosfomycin (antibiotic) solution for infusion

    - Metronidazole (antibiotic) solution for infusion

    - Molgramostim (immune system stimulating medication) or placebo

    A salt solution (sodium chloride) will also be administered into your abdominal cavity.

  3. Step 3

    Monitoring and sample collection

    Medical staff will collect samples of:

    - Fluid from your abdominal cavity

    - Blood samples for laboratory testing

    These samples will be used to measure various substances that indicate your body's response to the treatment.

  4. Step 4

    Recovery assessment

    Your recovery will be evaluated using a standardized questionnaire about your well-being.

    Medical staff will monitor your recovery progress through regular health checks and blood tests.

    The monitoring will include checking your kidney function, blood cell counts, and various proteins in your blood that indicate inflammation.

Who can join the trial?

5 criteria

  • You must be at least 18 years old
  • You must be scheduled for a surgical procedure where doctors have found peritonitis (inflammation of the tissue that lines your inner abdominal wall and organs)
  • Your peritonitis must be caused by damage to your large intestine (the lower part of your digestive system)
  • The infection must affect at least 2 areas of your abdomen
  • Both men and women can participate

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • Known allergic reactions to GM-CSF, metronidazole, or fosfomycin (medications used in the study)
  • Severe kidney disease (as it may affect how the medications are processed by the body)
  • Severe liver disease (as it may affect how the medications are processed by the body)
  • Current participation in other clinical trials
  • Inability to provide informed consent
  • History of adverse reactions to similar medications
  • Active cancer treatment
  • Compromised immune system (weakened ability to fight infections)
  • Severe heart conditions
  • Uncontrolled diabetes mellitus (high blood sugar levels)
  • History of seizures or neurological disorders
  • Active substance abuse
  • Mental health conditions that could affect participation
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Investigated drugs

Fosfomycin is an antibiotic medication used to treat bacterial infections. In this trial, it is administered directly into the abdominal cavity to fight infections in patients with widespread peritonitis (infection of the abdominal lining). Metronidazole is an antibiotic that specifically targets anaerobic bacteria and certain parasites. In this trial, it is used in combination with other medications to treat severe abdominal infections. GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) is a protein that stimulates the body's immune system by increasing the production of white blood cells. In this trial, it is used to help boost the body's natural defense against infection in the abdominal cavity. These medications are administered directly into the abdominal cavity during surgery to treat patients who have peritonitis affecting multiple areas of the abdomen.

What is already known about the treatment

  • Fosfomycin

    An antibiotic administered intraperitoneally for treating severe abdominal infections, particularly peritonitis. This broad-spectrum antibiotic works by disrupting bacterial cell wall synthesis by inhibiting the enzyme that catalyzes peptidoglycan formation, which is essential for bacterial survival. It belongs to the phosphonic acid antibiotic class and is particularly effective against many drug-resistant bacteria.

  • Metronidazole

    An antimicrobial medication administered intraperitoneally for treating infections caused by anaerobic bacteria and certain parasites, particularly in peritonitis cases. It works by entering bacterial cells and disrupting their DNA, leading to cell death. This medication belongs to the nitroimidazole class of antibiotics and is particularly effective against organisms that thrive in oxygen-poor environments.

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

    A protein-based medication administered intraperitoneally to stimulate the immune system's response to infection in peritonitis cases. This biological agent works by promoting the production and activation of white blood cells, specifically granulocytes and macrophages, which help fight bacterial infections. It belongs to the colony-stimulating factors class and helps enhance the body's natural defense mechanisms against infections.

Investigated diseases

Peritonitis - An inflammation of the peritoneum, which is the tissue that lines the inner wall of the abdomen and covers most of the abdominal organs. The condition typically begins with bacterial infection that causes the peritoneal tissue to become inflamed and irritated. Patients may experience abdominal pain, swelling of the abdomen, and fluid accumulation in the peritoneal cavity. The inflammation can spread throughout different areas of the abdomen, potentially affecting multiple quadrants (multiquadrant peritonitis). The condition can develop as a complication of other abdominal conditions or medical procedures.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520317-49-02Protocol code2025-GMF-1Estimated enrolment64 patientsSponsorRegion Sjaelland

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