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