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

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520317-49-00

Acronym

2025-GMF-1

Enrollment

Registered

2025-06-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-12

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 cytokine 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)

Interventions

DRUGMETRONIDAZOLE

DRUGMOLGRAMOSTIM

DRUGSaline Solution Basi 9 mg/ml solution for infusion

DRUGFOSFOMYCIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary translational endpoint: Change in cytokine levels in peritoneal dialysate., Primary clinical end point: Change in QoR-15	—

Secondary

Measure	Time 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)	—

Countries

Denmark

Outcome results

None listed

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