Prospective, Randomized, Controlled Trial Evaluating the Efficacy of a Lock-therapy With a Solution of Taurolidine/Citrate (TauroLock) vs Standard Saline Solution for the Primary Prevention of Catheter-related Infections (CLI) in Adult Patients Wtih a Non-hematological Cancer Treated With Intravenous Anti-tumor Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- central venous catheter-associated bloodstream infection (CLABSI)
研究概览
简要总结
The purpose of this study is to compare the efficacy of a lock taurolidine-citrate solution vs standard saline solution for primary prevention of central venous catheter-associated bloodstream infection in adult patients treated with intra-venous therapy for a solid tumor
详细描述
The central venous catheter (CVC)-associated bloodstream infection (CLABSI) represent a serious and persistent health problem in cancer patients with an implantable CVC receiving an intravenous (IV) anti-tumor therapy. The CLABSI include the CVC-associated bacteremia and the negative bloodstream local or generalized infections. CLABSI significantly increase morbidity and hospital costs. They can lead also to discontinuation of IV anti-tumor treatment, a severe sepsis, a septic shock or a death. Microbial colonization and biofilm development, which are resistant to antibiotic therapy, often lead to CVC replacement. CLABSI prevention is a key measure to improve clinical outcomes, particularly in patients at high risk. For this reason, CLABSI prevention is a national priority of the healthcare program. Taurolidine [bis-(1,1-dioxoperhydro-1,2,4-thiadiazinyl-4) methane] is an antimicrobial agent which kills and inhibits a wide range of micro-organisms in vitro, including multidrug resistant bacteria. A catheter lock solution was developed containing 1.35% taurolidine and 4% citrate. Due to the anti-adhesion activity of the taurolidine and anti-thrombotic properties of the citrate, this lock solution can disrupt bacterial adhesion to the inner surface of the implantable CVC preventing the production of biofilm. This lock solution showed a substantial reduction in the formation of biofilm and bacterial colonization of the inner surface of the implantable CVC is several prospective trials.
In a study of pediatric cancers receiving IV anti-tumor treatment, the use of a lock solution of taurolidine-citrate resulted in a reduction of Gram-positive CLABSI as compared to a control group of patients treated with a standard heparin lock solution. In another study of 71 pediatric patients, taurolidine-citrate solution reduced CLABSI compared with heparin (0.3 vs 1.3 infections per 1000 catheter-days, p: 0.03). Microbial colonization was found in 25.4% of the catheters. Regarding the toxicity, 7 patients only in the taurolidine-citrate group (20%) experienced side effects, the most being nausea, vomiting and abnormal sensations of taste.
Some clinical trials have also demonstrated the efficacy of taurolidine-citrate in terms of CLABSI reduction in patients on home total parenteral nutrition and in hemodialysis patients.
According to the French guidelines, an anti-bacterial lock therapy (preferably taurolidine) may be used as prevention in patients at increased risk of serious CLABSI complications. However, the effectiveness of the lock taurolidine-citrate solution for adult patients with solid tumors receiving an anti-tumor treatment via a totally implantable CVC is actually unknown and it remains to be assessed.
PRIMARY OBJECTIVE
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Performance Index (WHO score) ≤ 2
- •Patient with a solid cancer receiving an IV anti-tumor treatment
- •Presence of a totally implantable CVC
- •Anti-tumoral therapy administered by a totally implantable CVC
- •Metastatic and / or (neo) adjuvant treatment
- •Full hospitalised and / or day-hospital patients
- •Informed written consent
- •Social Health security insurance
排除标准
- •Hematological cancer patients
- •HIV-positive patients and/ or patients receiving an active immunosuppressive therapy
- •Patients presenting a febrile episode within 4 days prior to randomisation
- •Patients with neutropenia grade ≥ 2 (ANC ≤ 1000/mm3) on a blood testing older than 7 days
- •Patients on IV antibiotic therapy
- •Patients on total and / or peripheral parental nutrition
- •Patients with a previous CLABSI history
- •Allergy to citrate or taurolidine
- •Patients who are not able to give an informed consent
- •Patients under guardianship
- •Patients under judicial protection
- •Pregnant or breastfeeding woman
研究组 & 干预措施
TauroLock
solution of taurolidine-citrate
干预措施: Taurolock (Device)
Control
saline solution
干预措施: saline solution (Drug)
结局指标
主要结局
central venous catheter-associated bloodstream infection (CLABSI)
时间窗: during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months
incidence rates of CLABSI per 1000 catheter-days
次要结局
- Anti-tumor treatment CLABSI-related delay(during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months)
- Evaluation of the taurolidine-citrate solution-related adverse effects(during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months)
- days of CLABSI-related hospitalisation(during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months)
- Total CVC removal for CLABSI(during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months)
- Costs associated with the CLABSI management in the perspective of health insurance(during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months)