NCT02967341Unknown4 期
Validation of Central Venous (Port A Cath®) Blood Draws for Ciprofloxacin Pharmacokinetic Research in Patients Under Treatment for Childhood Cancer
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction
研究概览
简要总结
To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic studies of ciprofloxacin in patients under treatment for childhood cancer.
详细描述
The concentration of cipro will be determined using a validated high-performance liquid chromatographic (HPLC) method with fluorescence detection. Unbound concentration will be determined by adjusting the pH of the plasma samples to physiological pH (7.4) in a CO2 incubator, followed by ultrafiltration and extraction of ciprofloxacin from the ultrafiltrate (as described above) prior to injection onto the HPLC system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who
- •are between 1 month and 18 years of age
- •are under treatment for any type of childhood cancer
- •use ciprofloxacin for prophylaxis of febrile neutropenia as part of regular treatment
- •have a PAC for intravenous medication and blood draws.
排除标准
- •Children will be excluded from this study if we are unable to
- •obtain informed consent of both parents and assent of the child (if he/she is over 12 years of age)
- •aspire blood from the PAC.
结局指标
主要结局
Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction
时间窗: 1 hour
次要结局
未报告次要终点
研究者
研究点 (2)
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