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临床试验/EUCTR2009-011505-16-AT
EUCTR2009-011505-16-AT进行中(未招募)1 期

Pharmacokinetics of intraperitoneal and intravenous fosfomycin in automated peritoneal dialysis patients without peritonitis

Medizinische Universität Wien,KIM I,Klinische Abteilung für Infektionen u.Tropenmedizin0 个研究点目标入组 8 人开始时间: 2009年5月26日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
8

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Male or female, aged between 18 and 85 years
  • Patients on APD using Icodextrin (Extraneal) for the long daytime dwell
  • Willingness and ability to comply with the protocol
  • Signed informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • any systemic infection
  • peritonitis or catheter-related infection which required antibiotic treatment within 2 months prior to the start of the study .
  • Allergy or hypersensitivity against study drug.
  • Severe hepatic impairment (Child-Pugh Class C)
  • Pregnancy, or women of child bearing potential not willing to apply adequate contraception during study period
  • Any disease considered relevant for proper performance of the study or risks to the patient, at the discretion of the investigator

研究者

发起方
Medizinische Universität Wien,KIM I,Klinische Abteilung für Infektionen u.Tropenmedizin

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