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
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