Clinical trial • Phase III • Gastroenterology
MOLGRAMOSTIM for Peritonitis
Phase III trial of MOLGRAMOSTIM for Peritonitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Peritonitis
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme|Small molecule
Key dates
- Initial CTIS Submission Date
- 03-03-2025
- First CTIS Authorization Date
- 12-06-2025
Trial design
Randomised, placebo (saline solution basi 9 mg/ml solution for infusion) - intra-abdominal use (product: saline solution basi 9 mg/ml solution for infusion; route: intra-abdominal use; product max total amount specified as 500 ml in part i data).-controlled Phase III trial across 2 sites in Denmark.
- Randomised
- Yes
- Comparator
- Placebo (Saline Solution Basi 9 mg/ml solution for infusion) - intra-abdominal use (product: Saline Solution Basi 9 mg/ml solution for infusion; route: INTRA-ABDOMINAL USE; product max total amount specified as 500 ml in Part I data).
- Target Sample Size
- 32
Eligibility
Recruits 32 adults.
- Pregnancy Exclusion
- - Patients currently pregnant or breastfeeding.
Inclusion criteria
- {"criterion_text":"-\tAll patients age ≥ 18 undergoing surgical intervention with findings of peritonitis, due to a lesion in the large intestine, with the involvement of ≥2 quadrants"}
Exclusion criteria
- {"criterion_text":"-\tPatients with a previous allergic reaction to rhGM-CSF, fosfomycin or metronidazole"}
- {"criterion_text":"-\tPatients with American Society of Anesthesiologists (ASA) physical status >3"}
- {"criterion_text":"-\tPatients with WHO Performance status >3"}
- {"criterion_text":"-\tPatients with peritoneal carcinomatosis"}
- {"criterion_text":"-\tPatients currently in treatment for any malignant or hematological disease"}
- {"criterion_text":"-\tPatients active prescribed immunosuppressants"}
- {"criterion_text":"-\tPatients with an autoimmune disease in active treatment with immunomodulatory drugs"}
- {"criterion_text":"-\tPatients with the need of vacuum assisted closure (VAC)"}
- {"criterion_text":"-\tParticipating in another pharmacological intervention trial"}
- {"criterion_text":"-\tPatients currently pregnant or breastfeeding."}
- {"criterion_text":"-\tPatients with severe renal failure (eGFR < 30 ml/min)"}
- {"criterion_text":"-\tPatients with anticipated compliance problems as determined by the investigator"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Primary translational endpoint: Change in cytokine levels in peritoneal dialysate.","definition_or_measurement_approach":"Change in cytokine levels in peritoneal dialysate."}
- {"endpoint_text":"- Primary clinical end point: Change in QoR-15","definition_or_measurement_approach":"Change in QoR-15"}
Secondary endpoints
- {"endpoint_text":"- Macrophage phagocytosis assay on PBMCs","definition_or_measurement_approach":"Macrophage phagocytosis assay on PBMCs"}
- {"endpoint_text":"- Change in cytokine levels in peripheral blood (TNF-α, IL-1β, IL-6, IL-8, IL-10, MCP-1, GM-CSF)","definition_or_measurement_approach":"Change in cytokine levels in peripheral blood (TNF-α, IL-1β, IL-6, IL-8, IL-10, MCP-1, GM-CSF)"}
- {"endpoint_text":"- Change in various blood values: • Hematology, • K+, • Na+, • CRP, • Albumin, • Creatinine (incl. eGFR)","definition_or_measurement_approach":"Change in laboratory blood values (hematology and listed biochemistry parameters)"}
Recruitment
- Planned Sample Size
- 32
- Recruitment Window Months
- 60
- Consent Approach
- Informed consent documented; subject information and informed consent form available (document titles: 'Deltagerinformation', 'Dine rettigheder som forsgsperson i forsg med medicin'). Participants are adults (≥18).
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 32
Denmark
- Earliest CTIS Part Ii Submission Date
- 25-05-2025
- Latest Decision Or Authorization Date
- 12-06-2025
- Processing Time Days
- 18
- Number Of Sites
- 2
- Number Of Participants
- 32
Sites
- Site Name
- Region Sjaelland (Lykkebaekvej 1)
- Department Name
- Center for Surgical Science, Department of Surgery
- Principal Investigator Name
- Ismail Gögenur
- Principal Investigator Email
- igo@regsj.dk
- Contact Person Name
- Ismail Gögenur
- Contact Person Email
- igo@regsj.dk
- Site Name
- Slagelse Hospital (Ingemannsvej 18)
- Department Name
- Department of Surgery, Slagelse Hospital
- Principal Investigator Name
- Michael Tvilling Madsen
- Principal Investigator Email
- mitm@regsj.dk
- Contact Person Name
- Michael Tvilling Madsen
- Contact Person Email
- mitm@regsj.dk
Sponsor
Primary sponsor
- Full Name
- Region Sjaelland
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
Co-sponsors
- Reponex Pharmaceuticals A/S
Investigational products
- Investigational Product Name
- MOLGRAMOSTIM
- Active Substance
- MOLGRAMOSTIM
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRA-ABDOMINAL USE
- Route
- INTRA-ABDOMINAL USE
- Maximum Dose
- 50 µg
- Investigational Product Name
- FOSFOMYCIN
- Active Substance
- FOSFOMYCIN
- Modality
- Small molecule
- Routes Of Administration
- INTRA-ABDOMINAL USE
- Route
- INTRA-ABDOMINAL USE
- Maximum Dose
- 2000 mg
- Investigational Product Name
- METRONIDAZOLE
- Active Substance
- METRONIDAZOLE
- Modality
- Small molecule
- Routes Of Administration
- INTRA-ABDOMINAL USE
- Route
- INTRA-ABDOMINAL USE
- Maximum Dose
- 500 mg
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.