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NCT02333266 Clinical Trial

Bio-assay Development and Implementation for Fungal Infection Detection

Candidemia Clinical Trial

Official title:
Bio-assay Development and Implementation for Fungal Infection Detection

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02333266
Other study ID # S57146
Secondary ID
Status Withdrawn
Phase N/A
First received December 17, 2014
Last updated May 11, 2016
Start date June 2016

Study information
Verified date December 2015
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

- Candidemia

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Candidemia

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of Candida albicans with the newly developed FUNGDETECT sensor in blood samples from patients with candidemia due to Candida albicans 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. Blood samples will be collected at baseline from patients directly after informed consent is given No
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