NCT05781295招募中不适用
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in the Primary Prevention of Catheter-related Endoluminal Infection in Paediatric Oncology.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 9
- 主要终点
- Comparison of the incidence of catheter-related infection per 1000 catheter days.
研究概览
简要总结
Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology.
Multicentric, controlled, randomized and double-blind label study.
详细描述
The patient will be followed according to the type of pathology and the respective treatment protocol either Taurolock or physiological serum at each time cathter will be used.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient less than or equal to 21 years of age at inclusion.
- •Patient for whom a central catheter is planned to be inserted*, excluding a non-tunneled femoral or cervical external catheter or a peripherally inserted central catheter (as PICC line). *1st catheter placement or placement following a relapse (this placement must take place at least one month after previous catheter removal).
- •Patient treated for a cancer.
- •Patient with regular follow-up in the inclusion center.
- •Informed consent signed by the patient if adult or by legal representatives if minor.
- •Patient benefiting from a social security coverage.
- •Time between the date of catheter placement and the planned date for the first solution lock injection less than 6 weeks.
排除标准
- •Patient with retinoblastoma.
- •Allografted patient.
- •Patient with a life expectancy of less than 6 months.
- •Patient refusing to participate in the protocol.
- •Patient already receiving a central venous catheter-related infection prevention lock (ILCVC).
- •Patient with known allergy to citrate or (cyclo)-Taurolidine.
- •Patient taking other drugs with a known contraindication with citrate or (cyclo)-Taurolidine.
- •Patient with an external femoral catheter.
- •Patient with a PICCLINE-type peripheral venous inserted central catheter.
- •Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
- •Patient under guardianship and curatorship.
研究组 & 干预措施
TauroLock™
Experimental
The patient will be followed up to a maximum of 6 months after randomization after have a Taurlock™ injected each time catheter will be used.
干预措施: TaurolockTM (Device)
Physiological serum (NaCl 0.9%)
Placebo Comparator
The patient will be followed up to a maximum of 6 months after randomization after have a Physiological serum injected each time catheter will be used.
干预措施: Physiological serum (Device)
结局指标
主要结局
Comparison of the incidence of catheter-related infection per 1000 catheter days.
时间窗: 1000 catheter days
Comparison of the incidence of catheter-related infection per 1000 catheter days.
次要结局
- Incidence of catheter removal related to catheter complication.(through study completion, an average of 56 months)
- Incidence of catheter colonizations.(through study completion, an average of 56 months)
- Incidence of catheter occlusions.(through study completion, an average of 56 months)
- Catheter removal time related to catheter complication.(through study completion, an average of 56 months)
- Number and hospitalization duration related to catheter complications.(through study completion, an average of 56 months)
- Identification of microbiologic germs found in the hemocultures and catheter cultures after catheter removal for catheter infection.(through study completion, an average of 56 months)
- Incidence of local infections (with or without bacteremia).(through study completion, an average of 56 months)
- Incidence of thrombotic complications.(through study completion, an average of 56 months)
- Number and frequency of adverse events linked to lock.(through study completion, an average of 56 months)
研究者
研究点 (9)
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