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临床试验/NCT03571711
NCT03571711Unknown不适用

Single- and Multiple-dose Pharmacokinetics of Meropenem in Spontaneous Bacterial Peritonitis and Liver Cirrhosis

Hannover Medical School1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年6月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
15
试验地点
1
主要终点
Trough concentrations of meropenem in single- and multiple-dose pharmacokinetics

研究概览

简要总结

The emergence of multidrug-resistant bacteria has increased the use of meropenem in spontaneous bacterial peritonitis (SBP). Additionally, recent studies suggested female gender as an independent risk factor for mortality in SBP. Studies regarding possible sex dependent differences in meropenem pharmacokinetics in SBP are scarce. The aim of this study is to determine the pharmacokinetics of meropenem during SBP in female and male patients with liver cirrhosis to investigate whether pharmacodynamics therapy goals are met.

详细描述

Spontaneous bacterial Peritonitis (SBP) in liver cirrhosis is a severe and increasingly common disease, which is associated with high morbidity, mortality and high costs for the investigator's health care system. In addition to age and severity of comorbidities, female sex is associated with detrimental outcome. Delayed diagnosis and therapy of SBP may lead to a higher mortality in this patient population. Therefore, an early diagnosis and adequate anti-infective therapy is essential. Due to the accumulation of antimicrobial-resistant (AMR) pathogens, especially in nosocomial SBP, empirical application of broad-spectrum antibiotics is recommended in the therapy of SBP.During the use of antibiotic drugs in general, pharmacokinetic/pharmacodynamic (PK/PD) targets, as the achieved time period over the minimal inhibitory concentration (MIC), should be evaluated to increase drug efficacy and reduce AMR development. Pharmacokinetic studies of meropenem concentrations at the infection site in this particular group of patients are rare in the literature. Recent studies in critically ill patients showed highly variable meropenem concentrations in peritoneal fluid after iv administration. The aim of this study is to determine the pharmacokinetics of meropenem during SBP in female and male patients with liver cirrhosis to investigate whether pharmacodynamics therapy goals are met.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 - 75 years
  • Administration of meropenem
  • Diagnosis of liver cirrhosis
  • Diagnosis of spontaneous bacterial Peritonitis
  • Indication for peritoneal drainage catheter

排除标准

  • Incapacity to give informed consent
  • Participation in other studies
  • Pregnancy

研究组 & 干预措施

Meropenem therapy in SBP

Patients in a tertiary care Hospital with meropenem injection due to spontaneous bacterial Peritonitis.

干预措施: Meropenem Injection (Drug)

结局指标

主要结局

Trough concentrations of meropenem in single- and multiple-dose pharmacokinetics

时间窗: 5 days

Single- and multiple-dose pharmacokinetic measurements of meropenem concentrations in blood plasma and ascites fluid and evaluation of trough concentrations.

Time over MIC of meropenem in single- and multiple-dose pharmacokinetics

时间窗: 5 days

Single- and multiple-dose pharmacokinetic measurements of meropenem concentrations in blood plasma and ascites fluid and evaluation of achieved time period with drug concentration above the minimal inhibitory concentration breakpoint of 8 mg/L.

Peak concentrations of meropenem in single- and multiple-dose pharmacokinetics

时间窗: 5 days

Single- and multiple-dose pharmacokinetic measurements of meropenem concentrations in blood plasma and ascites fluid and evaluation of Peak Levels concentrations in blood plasma and ascites fluid and evaluation of peak concentrations.

Area under the curve of meropenem in single- and multiple-dose pharmacokinetics

时间窗: 5 days

Single- and multiple-dose pharmacokinetic measurements of meropenem concentrations in blood plasma and ascites fluid and evaluation of area under the curve characteristics

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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