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临床试验/NCT05257070
NCT05257070已完成不适用

The Clinical Validation of a Dried Blood Spot Method for Vancomycin and Creatinine

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
To clinically validate the DBS method for vancomycin and creatinine in comparison to venipuncture vancomycin and creatinine analysis

研究概览

简要总结

A widely used antibiotic is vancomycin. To ensure adequate exposure to vancomycin, drug doses are adjusted based on whole-blood concentration measurements, a practice known as therapeutic drug monitoring (TDM). The need for TDM of vancomycin is well established, as described in several national and international guidelines, for dose-optimization in order to achieve successful treatment and to prevent toxicity and reduce microbial resistance. A sampling method for TDM that has become more popular over the recent years is dried blood spotting (DBS). DBS is a design of blood sampling consisting of positioning a drop of capillary blood, preferably taken from the finger, on filter paper. Unlike venous blood sampling (the current gold standard for TDM of vancomycin), DBS seems to have advantages for the patient. The finger prick is less invasive than venipuncture. DBS also enables patients to perform one or multiple finger prick(s) themselves, with the possibility to sample at multiple time points. Due to the fact that vancomycin is nephrotoxic, it would be very efficient and convenient to measure creatinine in the same dried blood spot as the vancomycin. This study is a clinical validation study to validate the DBS assay for vancomycin.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical patients
  • Aged 18 and over
  • Able to understand written information and able to give informed consent
  • Treated with vancomycin
  • Able and willing to undergo a finger prick for dried blood spot sampling
  • Able and willing to fill in a questionnaire

排除标准

  • Unable to draw blood samples for study purposes

结局指标

主要结局

To clinically validate the DBS method for vancomycin and creatinine in comparison to venipuncture vancomycin and creatinine analysis

时间窗: 5 months

次要结局

  • Analyzing the differences in the measured concentrations in the dried blood spot made with blood obtained from venous sampling and capillary sampling.(5 months)
  • To investigate the patients' experience with the DBS method in comparison to venipuncture(5 months)
  • Evaluating the need of a correction factor and optimizing the correction factor when measuring the hematocrit in the DBS samples(5 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. B.C.M. (Brenda) de Winter

Assistant Professor

Erasmus Medical Center

研究点 (1)

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