Bio-assay Development and Implementation for Fungal Infection Detection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Detection of Candida albicans with the newly developed FUNGDETECT sensor in blood samples from patients with candidemia due to Candida albicans
研究概览
简要总结
The purpose of this study is to determine whether the newly developed biosensor can be used to detect and quantify fungal cells in human blood samples.
详细描述
The study discussed here is part of a broader research project (IOF project) that is aimed at the development and implementation of a point-of-care devices, in which Fiber-Optic Surface Plasmon Resonance (FO-SPR) is used as a detection system. This project includes the development and implementation of the (FUNGDETECT) sensor for fast and accurate detection of fungal pathogens in human blood samples. In first instance, the sensor will be tested in buffer solutions spiked with a known amount of Candida albicans cells. Further validation of the prototype includes detection of these cells in human blood samples. In a first experiment, detection of yeast cells will be performed in blood samples from 5 healthy volunteers each spiked with yeast cells from different Candida spp.. A second experiment includes the detection in blood samples from 15 patients who suffer from a candidemia. The blood samples will be collected from patients of University Hospitals (UZ) Leuven.
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
- 是
入选标准
- •Healthy volunteers for validation of the (FUNGDETECT) sensor (Spiked blood samples)
- •Candidemia
排除标准
- 未提供
结局指标
主要结局
Detection of Candida albicans with the newly developed FUNGDETECT sensor in blood samples from patients with candidemia due to Candida albicans
时间窗: Blood samples will be collected at baseline from patients directly after informed consent is given
Patients in the hospital and suspected to have a Candida infection will be tested for Candida infections via blood cultures. Blood samples for patients with a positive test will be taken immediately after the positive result and used to validate the FUNGDETECT sensor.
次要结局
未报告次要终点