Bio-assay Development and Implementation for Fungal Infection Detection

May 11, 2016 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients laying in the hospital that suffer from a candidemia.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Candidemia
Other: Candidemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Blood samples will be collected at baseline from patients directly after informed consent is given

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Study Director: Jeroen Lammertyn, Prof., KU Leuven
  • Principal Investigator: Katrien Lagrou, Prof., Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 7, 2015

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S57146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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