2024-520317-49-02招募中1 期
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)
Region Sjaelland, Reponex Pharmaceuticals A/S2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年8月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Primary translational endpoint: Change in IL-6 levels in peritoneal dialysate
研究概览
简要总结
To investigate if intraperitoneal administration of GM-CSF, metronidazole and fosfomycin can optimize the treatment of patients with multiquadrant peritonitis
研究设计
- 分配方式
- Randomized
- 主要目的
- Triple
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Primary translational endpoint: Change in IL-6 levels in peritoneal dialysate
Primary translational endpoint: Change in IL-6 levels in peritoneal dialysate
Primary clinical end point: Change in QoR-15
Primary clinical end point: Change in QoR-15
次要结局
- 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)
研究者
Ismail Gögenur
Scientific
Region Sjaelland
研究点 (2)
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