Clinical Trials for Peritonitis: Current Research and Treatment Studies
Peritonitis is a serious condition involving inflammation of the tissue lining the abdomen. Currently, 6 clinical trials are investigating new treatments for this condition, including antibiotic therapies, immune system support, and nutritional approaches. These studies are taking place across several European countries, including Denmark, France, Germany, Austria, and the Netherlands.
Clinical trial locations
- Austria
- Denmark
- Study of intraperitoneal fosfomycin, metronidazole and molgramostim treatment in patients with multi-quadrant peritonitis during abdominal surgery
- Study on Early vs. Delayed Supplementary Parenteral Nutrition with SmofKabiven for Patients After Major Emergency Abdominal Surgery
- Study on Intraperitoneal Treatment with Fosfomycin, Metronidazole, and Molgramostim for Patients with Multi-Quadrant Peritonitis Undergoing Abdominal Surgery
- France
- Germany
- Netherlands
Study of caspofungin compared to placebo for treating yeast infections in the abdomen in intensive care unit patients
This trial is testing caspofungin, an antifungal medication, for patients in intensive care units who develop yeast infections in the abdomen. The study takes place in France and focuses on a specific type of infection called intra-abdominal candidiasis, which can lead to fungal inflammation of the abdominal lining.
Main inclusion criteria: Participants must be at least 18 years old with active health insurance, admitted to the ICU after surgery for an abdominal infection. They must have either a suspected yeast infection with a special score of 3 or higher, or a confirmed yeast infection found in abdominal fluid during surgery. Both men and women can participate.
Main exclusion criteria: The study excludes people younger than 18 or older than 65, those with known allergies to antifungal medications, pregnant or breastfeeding women, patients with severe liver or kidney disease, those receiving immunosuppressive therapy, patients with a history of organ transplantation, and those with severe heart conditions or other serious infections requiring additional treatment.
Focus and goal: The trial aims to determine if caspofungin can reduce treatment failure rates compared to placebo. Patients receive daily doses through an intravenous line for up to 8 weeks. Doctors monitor patients for 28 days after starting treatment to assess effectiveness, with extended follow-up continuing to 90 days.
Investigational drug: Caspofungin (brand name Cancidas) is available in 50 mg and 70 mg strengths. It works by disrupting fungal cell wall formation, preventing the infection from spreading.
Study on Early vs. Delayed Supplementary Parenteral Nutrition with SmofKabiven for Patients After Major Emergency Abdominal Surgery
This Danish trial examines the timing of nutritional support for patients recovering from major emergency abdominal surgery. The study compares providing nutrition through the veins early after surgery versus delaying this support.
Main inclusion criteria: Participants must be 18 years or older and have undergone a primary emergency midline laparotomy. They must have a preoperative nutritional risk score of less than 7, no medical reasons preventing eating or tube feeding after surgery, and an intake of less than 30% of recommended calories on the second day after surgery.
Main exclusion criteria: The study excludes patients who have not undergone major emergency abdominal surgery, those outside the specified age range, participants in excluded clinical trial groups, and members of vulnerable populations who might need special protection.
Focus and goal: The trial investigates whether the timing of supplementary nutrition affects the risk of hospital-acquired infections. Researchers monitor complications, hospital stay length, and mortality rates at 30, 90, and 180 days after surgery. They also track energy and protein intake during hospitalization.
Investigational treatment: SmofKabiven and SmofKabiven Perifer are emulsions for infusion containing amino acids, oils, and minerals to support recovery. These are administered through an intravenous line, bypassing the digestive system to provide essential nutrients.
Study on the Effects of Immunoglobulin A, G, and M in Patients with Peritonitis and Sepsis After Infection Control
This trial, conducted in Germany and Austria, studies Pentaglobin for treating patients with inflammation of the abdominal lining and sepsis. The condition occurs when the body’s response to infection causes tissue damage.
Main inclusion criteria: Participants must have a diagnosis of secondary or quaternary inflammation of the abdominal lining, with a procedure to control the infection source performed within 6 hours of the decision. They must have sepsis or septic shock, a SOFA score of 8 or higher measuring organ function, and IL-6 blood levels of 1000 pg/ml or more. Antibiotic treatment must start within 12 hours of ICU admission. Informed consent is required.
Main exclusion criteria: The study excludes patients with secondary or quaternary forms of the condition who are not first-time cases, and those with sepsis.
Focus and goal: The trial monitors multiple organ function over seven days after infection control, tracking the lungs, heart, kidneys, liver, and blood. Secondary evaluations include monitoring death rates within 28 and 90 days and changes in organ failure scores by day 5.
Investigational drug: Pentaglobin is a solution containing immunoglobulins, proteins that help the immune system fight infections. It is administered intravenously to enhance immune response and reduce organ failure severity.
Study on Using Gentamicin and Clindamycin to Prevent Abscesses After Surgery for Complicated Appendicitis in Patients
This Dutch trial investigates whether washing the abdominal area with antibiotics during appendix removal surgery can prevent abscess formation in patients with complicated appendicitis.
Main inclusion criteria: Participants must be at least 8 years old with a preoperative diagnosis of acute appendicitis, with or without suspicion of complications. They must be undergoing laparoscopic appendectomy, with complicated appendicitis confirmed during surgery. Both males and females can participate, and signed written consent is required.
Main exclusion criteria: The study excludes patients with known allergies to gentamicin or clindamycin, those with a history of severe allergic reactions to any medications, pregnant or breastfeeding women, patients with other serious health conditions that might interfere with the study, those unable to follow study procedures, and participants in another clinical trial.
Focus and goal: The trial evaluates whether antibiotic lavage can reduce abscess risk by at least 50%. After standard appendix removal, the abdominal cavity is washed with gentamicin and clindamycin for 3 minutes. Patients are monitored for 30 days for abscess development, with additional observation of wound infections and recovery for up to 90 days.
Investigational drugs: Gentamicin and clindamycin are antibiotics applied directly to the abdominal area during surgery. The combination aims to prevent bacterial infections and abscess formation after appendectomy.
Study of intraperitoneal fosfomycin, metronidazole and molgramostim treatment in patients with multi-quadrant peritonitis during abdominal surgery
This Danish study examines whether delivering medications directly into the abdominal cavity can improve outcomes for patients with infection spreading to multiple abdominal areas.
Main inclusion criteria: Participants must be at least 18 years old and scheduled for surgery where doctors have found inflammation affecting at least 2 areas of the abdomen, caused by damage to the large intestine. Both men and women can participate.
Main exclusion criteria: The study excludes people younger than 18 or older than 65, pregnant or breastfeeding women, those with known allergic reactions to GM-CSF, metronidazole, or fosfomycin, patients with severe kidney or liver disease, those in other clinical trials, people unable to provide informed consent, those with history of adverse reactions to similar medications, active cancer treatment, compromised immune system, severe heart conditions, uncontrolled diabetes, history of seizures or neurological disorders, active substance abuse, and mental health conditions affecting participation.
Focus and goal: The trial tests whether medications delivered directly into the abdominal cavity during surgery can improve treatment outcomes. Doctors collect abdominal fluid and blood samples to measure treatment effectiveness and monitor recovery after surgery.
Investigational drugs: Fosfomycin and metronidazole are antibiotics fighting bacterial infections, administered directly into the abdominal cavity. Molgramostim (also called Repomol) is a substance that boosts the immune system. Some patients receive these medications while others receive placebo with sodium chloride solution.
Study on Intraperitoneal Treatment with Fosfomycin, Metronidazole, and Molgramostim for Patients with Multi-Quadrant Peritonitis Undergoing Abdominal Surgery
This Danish trial explores a combination of medications administered directly into the abdominal area for patients with severe infection affecting multiple abdominal regions.
Main inclusion criteria: Participants must be 18 years or older, undergoing surgical intervention where they have been found to have inflammation of the abdominal lining due to a problem in the large intestine. The infection must involve two or more quadrants of the abdomen. Both male and female patients can participate.
Main exclusion criteria: The study excludes patients who do not have inflammation of the abdominal lining, those outside the specified age range, and members of vulnerable populations who may have limited ability to give informed consent or are at higher risk of harm.
Focus and goal: The trial determines if the medication combination can optimize treatment for patients with multi-quadrant inflammation. Participants receive either the medication combination or placebo, with regular assessments tracking progress and biological markers to evaluate treatment effectiveness. The study continues until 2030, with recruitment starting in 2025.
Investigational drugs: Fosfomycin and metronidazole are antibiotics delivered directly to the infection site. Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) stimulates white blood cell production, boosting the immune response to help the body fight the infection.
Summary
The six ongoing clinical trials for peritonitis demonstrate diverse approaches to treating this serious condition. Research is concentrated in Northern and Central Europe, with Denmark hosting three trials, and individual studies taking place in France, Germany, Austria, and the Netherlands.
A notable trend is the focus on direct intraperitoneal delivery of medications, with three Danish trials investigating whether delivering antibiotics and immune-stimulating substances directly into the abdominal cavity improves outcomes. Two trials specifically test the combination of fosfomycin, metronidazole, and molgramostim for multi-quadrant infections.
The trials address different aspects of abdominal infections: fungal infections in intensive care patients, nutritional support timing after emergency surgery, immune system support with immunoglobulins for sepsis, and prevention of complications after appendix removal. This variety reflects the complexity of treating abdominal infections and the need for specialized approaches depending on the underlying cause and severity.
Age requirements vary across studies, with most accepting adults 18 and older, while one trial includes children as young as 8 years. Several trials have upper age limits, excluding patients over 65. Common exclusion criteria include pregnancy, severe organ disease, and compromised immune systems, highlighting the need for careful patient selection in these studies of serious infections.
