Clinical trial • Phase III • Gastroenterology
Molgramostim for Peritonitis | Secondary peritonitis
Phase III trial of Molgramostim for Peritonitis | Secondary peritonitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Peritonitis | Secondary peritonitis
- Trial Stage
- Phase III
- Drug Modality
- Small molecule | Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 13-06-2025
- First CTIS Authorization Date
- 22-08-2025
Trial design
Randomised, placebo: saline solution basi 9 mg/ml solution for infusion (sodium chloride) — route: intra-abdominal; product listing shows max daily/total amount 500 ml (no detailed schedule provided).-controlled Phase III trial across 2 sites in Denmark.
- Randomised
- Yes
- Comparator
- Placebo: Saline Solution Basi 9 mg/ml solution for infusion (sodium chloride) — route: intra-abdominal; product listing shows max daily/total amount 500 ml (no detailed schedule provided).
- Target Sample Size
- 32
- Trial Duration For Participant
- 28
Eligibility
Recruits 32 Vulnerable population not selected; participants are adults (age ≥18). Subject information and informed consent form documents are listed but no further details on assent or special consent procedures for vulnerable groups are provided in the available data..
- Pregnancy Exclusion
- Patients currently pregnant or breastfeeding.
- Vulnerable Population
- Vulnerable population not selected; participants are adults (age ≥18). Subject information and informed consent form documents are listed but no further details on assent or special consent procedures for vulnerable groups are provided in the available data.
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":"- Patients with a previous allergic reaction to rhGM-CSF, fosfomycin or metronidazole"}
- {"criterion_text":"- Patients with American Society of Anesthesiologists (ASA) physical status >3"}
- {"criterion_text":"- Patients with WHO Performance status >3"}
- {"criterion_text":"- Patients with peritoneal carcinomatosis"}
- {"criterion_text":"- Patients currently in treatment for any malignant or hematological disease"}
- {"criterion_text":"- Patients active prescribed immunosuppressants"}
- {"criterion_text":"- Patients with an autoimmune disease in active treatment with immunomodulatory drugs"}
- {"criterion_text":"- Patients with the need of vacuum assisted closure (VAC)"}
- {"criterion_text":"- Participating in another pharmacological intervention trial"}
- {"criterion_text":"- Patients currently pregnant or breastfeeding."}
- {"criterion_text":"- Patients with severe renal failure (eGFR < 30 ml/min)"}
- {"criterion_text":"- Patients with anticipated compliance problems as determined by the investigator"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Clinical failure at POD28 (composite outcome: either death, surgical site wound infection, unplanned surgery or drainage due to complication or recurrence of intraabdominal infection or initiation of non-trial antibiotics due to worsening of intraabdominal infection)","definition_or_measurement_approach":"Composite outcome assessed at post-operative day 28 (POD28); components defined as either death, surgical site wound infection, unplanned surgery or drainage due to complication or recurrence of intraabdominal infection, or initiation of non-trial antibiotics due to worsening of intraabdominal infection (as stated in parentheses)."}
Secondary endpoints
- {"endpoint_text":"- Macrophage phagocytosis assay on PBMCs","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change in cytokine levels in peripheral blood","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change in various blood values: • Hematology, • K+, • Na+, • CRP, • Albumin, • Creatinine (incl. eGFR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Quality of recovery-15","definition_or_measurement_approach":""}
- {"endpoint_text":"- Postoperative complications according to Clavien-Dindo","definition_or_measurement_approach":""}
- {"endpoint_text":"- Length of hospital stay","definition_or_measurement_approach":""}
- {"endpoint_text":"- length of intensive care unit stay","definition_or_measurement_approach":""}
- {"endpoint_text":"- Duration of intravenous antibiotics treatment","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 32
- Recruitment Window Months
- 55
- Consent Approach
- Informed consent obtained using subject information and informed consent form documents (document titles listed). The available metadata does not provide details on assent, age-specific consent documents or languages available.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 32
Denmark
- Earliest CTIS Part Ii Submission Date
- 19-06-2025
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 251
- 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":"[{\"id\":970817,\"code\":\"1\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
Co-sponsors
- Reponex Pharmaceuticals A/S
Investigational products
- Investigational Product Name
- Repomol
- Active Substance
- Molgramostim
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRA-ABDOMINAL USE
- Route
- Intra-abdominal
- Authorisation Status
- No marketing authorisation number listed in productDictionaryInfo (prodAuthStatus: 1)
- Starting Dose
- 50 µg (max daily/total amount listed)
- Maximum Dose
- 50 µg
- Investigational Product Name
- Fosfomycin "Infectopharm", pulver til infusionsvæske, opløsning 40 mg/ml
- Active Substance
- Fosfomycin
- Modality
- Small molecule
- Routes Of Administration
- INTRA-ABDOMINAL USE
- Route
- Intra-abdominal
- Authorisation Status
- Marketing authorisation present (mrpNumber: NL/H/4627/001; prodAuthStatus: 2)
- Starting Dose
- 4 g (max daily/total amount listed)
- Maximum Dose
- 4 g
- Investigational Product Name
- Metronidazol ”Baxter” Viaflo, infusionsvæske, opløsning
- Active Substance
- Metronidazole
- Modality
- Small molecule
- Routes Of Administration
- INTRA-ABDOMINAL USE
- Route
- Intra-abdominal
- Authorisation Status
- Marketing authorisation present (mrpNumber: DK/H/2896/001; authorisationCountryCode: DK; prodAuthStatus: 2)
- Starting Dose
- 500 mg (max daily/total amount listed)
- Maximum Dose
- 500 mg
- Investigational Product Name
- Saline Solution Basi 9 mg/ml solution for infusion
- Active Substance
- Sodium chloride
- Modality
- Small molecule
- Routes Of Administration
- INTRA-ABDOMINAL USE
- Route
- Intra-abdominal
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 5211800; authorisationCountryCode: MT; prodAuthStatus: 2)
- Starting Dose
- 500 ml (max daily/total amount listed)
- Maximum Dose
- 500 ml
- Combination Treatment
- Yes
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