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临床试验/EUCTR2020-001033-12-DK
EUCTR2020-001033-12-DK进行中(未招募)1 期

PROPHYLACTIC ANTIBIOTIC TREATMENTIN END-STAGE KIDNEY DISEASE AND CENTRAL VENOUS CATHETER ASHEMODIALYSIS VASCULAR ACCESS

iels Eske Bruun0 个研究点目标入组 800 人开始时间: 2020年4月17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
800

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

  • End Stage Kidney Disease (ESKD) patients who receive an uncuffed or cuffed CVC for expected chronic HD, regardless of previous ESKD treatment modality (PD or KTX) and hemodialysis access (AV-fistula or AV-graft))
  • > 18 years
  • Ability to understand the study background, risk and benefit of treatment and to give written 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 300
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 500

排除标准

  • Unable to give informed consent
  • Known intolerance to beta-lactam antibiotics and clindamycin
  • Active infection treated with antibiotics.
  • Pregnancy. In women of childbearing age, an approved birth control must be ensured.
  • Patients may be rescreened later i.e. within a time period of one month from start of HD, if exclusion criteria are reversible

研究者

发起方
iels Eske Bruun

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