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Intraperitoneal treatment with fosfomycin, metronidazole and recombinant human granulocyte-macrophage colony-stimulating factor in patients with multi-quadrant peritonitis undergoing abdominal surgery: A randomized placebo-controlled trial (TRIPLE)

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520317-49-02
Acronym
2025-GMF-1
Enrollment
32
Registered
2025-08-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peritonitis

Brief summary

Primary translational endpoint: Change in IL-6 levels in peritoneal dialysate, Primary clinical end point: Change in QoR-15

Detailed description

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), Change in cytokine levels in peritoneal dialysate (TNF-α, IL-1β, IL-8, IL-10, MCP-1, GM-CSF)

Interventions

DRUGFosfomycin "Infectopharm"
DRUGpulver til infusionsvæske
DRUGopløsning 40 mg/ml
DRUGSaline Solution Basi 9 mg/ml solution for infusion
DRUGMetronidazol ”Baxter” Viaflo
DRUGinfusionsvæske
DRUGopløsning
DRUGRepomol

Sponsors

Region Sjaelland, Reponex Pharmaceuticals A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary translational endpoint: Change in IL-6 levels in peritoneal dialysate, Primary clinical end point: Change in QoR-15—

Secondary

MeasureTime frame
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), Change in cytokine levels in peritoneal dialysate (TNF-α, IL-1β, IL-8, IL-10, MCP-1, GM-CSF)—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026