DRKS00026042招募中未知
Multicenter Post Market Clinical Follow-up (PMCF) investigation to evaluate safety and effectiveness of Geistlich TauroSept® used as adjunctive treatment in patients with catheter related blood stream infection (CRBSI)
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1.Written informed consent
- •2.Age 18 years or older
- •3.Cancer patients having implanted central vascular access device (i.e. port-a-cath) with CRBSI
- •4.Estimated life expectancy of > 6 months
排除标准
- •1.Central venous access device (CVAD) exchange in the past
- •2.Indication for catheter removal due to technical problems, catheter dysfunction
- •3.Previous or current use of catheter lock solution (CLS) containing taurolidine
- •4.Implanted an antibiotic coated or silver impregnated central venous access device (CVAD)
- •5.Symptoms requiring immediate line removal at the discretion of an independent surgeon/ physician (i.e. not member of the investigational team)
- •6.Blood stream infection sourced by exit site infection or other than CVAD
- •7.Blood stream infection caused by fungi
- •8.History of CRBSI
- •9.Severe diseases (such as myocardial infarction, impaired kidney or liver function, etc.) upon decision of the investigator
- •10.Known allergy to taurolidine or their excipients
- •11.Autoimmune disease
- •12.Uncontrolled metabolic disease (e.g. uncontrolled diabetes)
- •13.Immunosuppressive therapy
- •14.Any clinically significant abnormalities in blood coagulation requiring intervention
- •15.Known or suspected noncompliance, drug or alcohol abuse
- •16.Inability to follow the procedures of the clinical investigation
- •17.Vulnerable population
- •18.Women of childbearing age who are not using highly effective method of birth control
- •19.Pregnant or breast-feeding women
- •20.Participation in another investigation with investigational drug, biologics or device within the 26 weeks preceding the present investigation
- •21.Participation in another clinical investigation during the present investigation
研究者
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