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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Slagelse Hospital	Slagelse	Denmark
Region Sjaelland	Holbæk	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.09.2025

Trial locations

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.

Investigated diseases:

Peritonitis

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 ID:

2024-520317-49-02

Protocol code:

2025-GMF-1

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?