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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

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

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Not yet recruiting
01.04.2025

Trial locations

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.

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 ID:
2024-520317-49-00
Protocol code:
2025-GMF-1
Trial Phase:
Human Pharmacology (Phase I) – Other

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