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临床试验/NCT07084428
NCT07084428进行中(未招募)不适用

Pancreatic Antibiotic Concentration Evaluation Assessment

Brno University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
Antibiotic concentration ratio between pancreatic fluid and plasma

研究概览

简要总结

This observational study aims to evaluate the penetration of intravenously administered antibiotics into pancreatic fluid collections in patients with suspected infected walled-off pancreatic necrosis (WOPN). In selected patients undergoing percutaneous or endoscopic drainage of the collection as part of their clinical care, a small sample of pancreatic fluid will be collected and analyzed to determine the concentration of the administered antibiotic.

At the same time, a blood sample will be taken to assess the antibiotic concentration in plasma. By comparing the concentrations in pancreatic fluid and plasma, the study seeks to determine the extent to which different antibiotics (e.g., meropenem or piperacillin-tazobactam) reach the site of infection within the pancreas.

All procedures performed as part of the study, with the exception of the antibiotic concentration measurement, are standard components of routine care for patients with complicated acute pancreatitis. Participation in the study does not alter the diagnostic or therapeutic management of the patient. Patients provide written informed consent before enrollment.

The results of this study may help optimize antibiotic dosing in patients with infected pancreatic collections and contribute to more effective and individualized treatment strategies in the future.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 18 years
  • •Signed informed consent
  • •Undergoing percutaneous or endoscopic drainage/puncture of a pancreatic fluid collection

排除标准

  • •- Failure or refusal to sign informed consent

结局指标

主要结局

Antibiotic concentration ratio between pancreatic fluid and plasma

时间窗: Within 6 hours after antibiotic administration

Ratio of antibiotic concentration in pancreatic fluid (WOPN) to plasma concentration, determined from simultaneously collected samples after intravenous antibiotic administration

次要结局

  • Measured concentrations of antibiotics in pancreatic fluid and plasma(Within 6 hours after antibiotic administration)

研究者

发起方
Brno University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Harazim

Dr.

Brno University Hospital

研究点 (1)

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