Bio-assay Development and Implementation for Fungal Infection Detection

Withdrawn

• Conditions: Candidemia
• Interventions: Other: Candidemia

• Registration Number: NCT02333266
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-07
• Status Verified: 2015-12
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12
• Study Start: 2016-06
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Healthy volunteers for validation of the (FUNGDETECT) sensor (Spiked blood samples)
• Candidemia

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Candidemia	Candidemia	0

Primary Outcome Measures

Name	Time	Method
Detection of Candida albicans with the newly developed FUNGDETECT sensor in blood samples from patients with candidemia due to Candida albicans	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.