Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Not authorised
Participants planned
32
Countries
1
Sites
2
peritonitis
To investigate if intraperitoneal administration of GM-CSF, metronidazole and fosfomycin can optimize the treatment of patients with multiquadrant peritonitis
Key facts
- Sponsor
- Region Sjaelland, Reponex Pharmaceuticals A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2025-06-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic, Efficacy
To investigate if intraperitoneal administration of GM-CSF, metronidazole and fosfomycin can optimize the treatment of patients with multiquadrant peritonitis
Conditions and MedDRA coding
peritonitis
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | TRIPLE To investigate if intraperitoneal administration of GM-CSF, metronidazole and fosfomycin can optimize the treatment of patients with multiquadrant peritonitis
|
Randomised Controlled | None | Arm A: Intervention (GM-CSF + Metronidazole + Fosfomycin) Arm B: Placebo (Saline) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - All 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 1
- - Patients with a previous allergic reaction to rhGM-CSF, fosfomycin or metronidazole - Patients with American Society of Anesthesiologists (ASA) physical status >3 - Patients with WHO Performance status >3 - Patients with peritoneal carcinomatosis - Patients currently in treatment for any malignant or hematological disease - Patients active prescribed immunosuppressants - Patients with an autoimmune disease in active treatment with immunomodulatory drugs - Patients with the need of vacuum assisted closure (VAC) - Participating in another pharmacological intervention trial - Patients currently pregnant or breastfeeding. - Patients with severe renal failure (eGFR < 30 ml/min) - Patients with anticipated compliance problems as determined by the investigator
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Primary translational endpoint: Change in cytokine levels in peritoneal dialysate.
- Primary clinical end point: Change in QoR-15
Secondary endpoints 3
- Macrophage phagocytosis assay on PBMCs
- Change in cytokine levels in peripheral blood (TNF-α, IL-1β, IL-6, IL-8, IL-10, MCP-1, GM-CSF)
- Change in various blood values: • Hematology, • K+, • Na+, • CRP, • Albumin, • Creatinine (incl. eGFR)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SUB08922MIG · Substance
- Active substance
- Metronidazole
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRA-ABDOMINAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09040MIG · Substance
- Active substance
- Molgramostim
- Pharmaceutical form
- LYOPHILISATE AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRA-ABDOMINAL USE
- Max daily dose
- 50 µg microgram(s)
- Max total dose
- 50 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07797MIG · Substance
- Active substance
- Fosfomycin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRA-ABDOMINAL USE
- Max daily dose
- 2000 mg milligram(s)
- Max total dose
- 2000 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Saline Solution Basi 9 mg/ml solution for infusion
PRD11121726 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRA-ABDOMINAL USE
- Max daily dose
- 500 ml millilitre(s)
- Max total dose
- 500 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 5211800
- MA holder
- LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A.
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Sjaelland
- Sponsor organisation
- Region Sjaelland
- Address
- Lykkebaekvej 1
- City
- Koege
- Postcode
- 4600
- Country
- Denmark
Scientific contact point
- Organisation
- Region Sjaelland
- Contact name
- Ismail Gögenur
Public contact point
- Organisation
- Region Sjaelland
- Contact name
- Ismail Gögenur
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Reponex Pharmaceuticals A/S
- Sponsor organisation
- Reponex Pharmaceuticals A/S
- Address
- Slotsmarken 12, 1 Th
- City
- Hoersholm
- Postcode
- 2970
- Country
- Denmark
Scientific contact point
- Organisation
- Region Sjaelland
- Contact name
- Ismail Gögenur
Public contact point
- Organisation
- Region Sjaelland
- Contact name
- Ismail Gögenur
Sponsor responsibilities
- Article 77 compliance
- Region Sjaelland
- Contact point sponsor
- Region Sjaelland
- Article 77 implementation
- Region Sjaelland
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Not authorised | 32 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Sprgeskema QOR 15 | 1 |
| Recruitment arrangements (for publication) | recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | Deltagerinformation | 3 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Fosfomycin SPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Metronidazol SPC | 1 |
| Synopsis of the protocol (for publication) | peritonitis protocol | 1.4 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-03 | Denmark | Not acceptable 2025-05-26
|
2025-06-12 |