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WithdrawnNCT02333266Updated May 12, 2016

Bio-assay Development and Implementation for Fungal Infection Detection

An observational study in Candidemia, sponsored by Universitaire Ziekenhuizen KU Leuven. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-12.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Why this study was withdrawn
The bioassay development is too difficult.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Candidemia

Keywords

  • Candida bloodstream infection
  • Detection fungal cells
  • Fiber-Optic Surface Plasmon Resonance (FO-SPR)
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients laying in the hospital that suffer from a candidemia.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Candidemia

    0

    Other: Candidemia

Interventions

  • OtherCandidemia
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Blood samples will be collected at baseline from patients directly after informed consent is given

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02333266
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Jan 7, 2015
Start date
Jun 2016
Primary completion
Dec 2017 (estimated)
Last update
May 12, 2016

Study contacts

Jeroen Lammertyn, Prof.
study director · KU Leuven
Katrien Lagrou, Prof.
principal investigator · Universitaire Ziekenhuizen KU Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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