Bio-assay Development and Implementation for Fungal Infection Detection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Candidemia
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary Endpoint
- Detection of Candida albicans with the newly developed FUNGDETECT sensor in blood samples from patients with candidemia due to Candida albicans
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers for validation of the (FUNGDETECT) sensor (Spiked blood samples)
- •Candidemia
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Detection of Candida albicans with the newly developed FUNGDETECT sensor in blood samples from patients with candidemia due to Candida albicans
Time Frame: 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.