Micafungin Lock Therapy to Clear Fungemia While Attempting to Preserve Central Venous Catheters
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Central vascular catheter preserved during lock therapy as a result of resolution of symptoms and negative cultures within 96h.
研究概览
简要总结
The study proposes to investigate, in children admitted at Children's Medical Center at Dallas, the effectiveness of antimicrobial lock therapy (ALT) with Micafungin in combination with systemic antifungal therapy in catheter-related fungal infections in order to salvage highly needed central venous catheter (CVC) and at the same time to investigate the effectiveness of Micafungin alone as systemic therapy in the treatment of Candidemia in a pediatric population.
详细描述
The antimicrobial lock therapy (ALT) consists of filling a catheter lumen with a supraphysiologic concentration (100- to 1000- fold higher) of an antimicrobial agent and allowing it to dwell (lock) for several hours in an attempt to sterilize the lumen. Advantages of the ALT are: the ability to administer high local concentrations; the ease of administration; the cost-savings and vein access-savings by decreasing the number of surgical procedures in an operating room for catheter replacement; the decrease in possible surgical complications and risks. The Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America and others recommend the ALT for the treatment of uncomplicated bacteremias. This technique however is not currently recommended for the treatment of catheter-related fungal infections, primarily due to lack of adequate data. This study plans to enroll approximately 20 children admitted to the Children's Medical Center at Dallas in high need of central venous catheters or with evidence of fungemia in this study to investigate the effectiveness of ALT with Micafungin against fungal infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children, 6 months-18 yrs, with a central line fungal infection, presumed Candida, admitted at Children's Medical Center.
- •Signed informed consent by parents and assent by minor if applicable.
- •Subjects with likely survival beyond 1 week.
排除标准
- •Pocket, tunnel or exit-site infection
- •Known allergic reactions to the Micafungin or echinocandins.
- •Severe systemic symptoms (disseminated candidemia, fungal balls, endocarditis)
- •Mixed infections
- •Inability to lock the catheter lumen for minimum 8h because of other medications administration
- •Subjects requiring ECMO or CVVH.
- •Patients with HIV, congenital immunodeficiencies.
- •Positive pregnancy test or breastfeeding.
研究组 & 干预措施
1
ALT with placebo with systemic Micafungin therapy
干预措施: Micafungin lock therapy (Drug)
2
ALT with Micafungin and heparin with systemic Micafungin therapy
干预措施: Micafungin lock therapy (Drug)
结局指标
主要结局
Central vascular catheter preserved during lock therapy as a result of resolution of symptoms and negative cultures within 96h.
时间窗: 96 hours
次要结局
- Descriptive analysis of safety profile of patients receiving ALT and systemic micafungin(Up to one month)