跳至主要内容
临床试验/NCT00545831
NCT00545831终止不适用

Prevention of Central Veinous Device Related Sepsis Relapse With Taurolidine in Patients on Parenteral Nutrition in Long-term Home

University Hospital, Rouen8 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2007年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
39
试验地点
8
主要终点
Number of recurrence of catheter-related infection in each group

研究概览

简要总结

Home parenteral nutrition (HPN) is a validated technique for patients with various intestinal disease leading to chronic malabsorption or obstruction, whatever the aetiology. Intravascular catheter-related bloodstream infections (CRBSI) is the more frequent complication of patients with HPN and an important cause of morbidity and mortality in these patients. Moreover, CRBSI often recur after a first treatment of the catheter with a combination of an antibiotic lock on the catheter and systemic intravenous antibiotics. In more than 50 % of the cases, another CRBSI will occur in a median delay of 5 months.

The aim of the study is to evaluate the efficacy of a taurolidine lock secondary prophylaxis on CRBSI recurrence in HPN patients.

Study population is separated in 2 groups, the first one receiving the Taurolock and the second one receiving a placebo. This is a randomized double-blind six-month study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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 superior to 18 years
  • Home parenteral nutrition on tunnelized central venous catheters
  • Bloodstream infection confirmed by differential hemocultures
  • Informed consent form signed
  • Negative B-HCG test

排除标准

  • Subject unable to give his informed consent
  • Pregnancy
  • Subject who have a two or three-way catheter, or a non-tunnelized central venous catheter
  • Hospital related infection
  • Central venous catheters placed since less than 15 days
  • Neutropenia < 500 PNN/mm3
  • Fungal Infection, polymicrobial who need ablation of the central venous catheters
  • No-response to clinical treatment of the Infection
  • Septic thrombophlebitis
  • Chemotherapy ongoing
  • On going malignancy

结局指标

主要结局

Number of recurrence of catheter-related infection in each group

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (8)

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