NCT02333266

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

May 12, 2016

Status Verified

December 1, 2015

Enrollment Period

1.5 years

First QC Date

December 17, 2014

Last Update Submit

May 11, 2016

Conditions

Candidemia

Keywords

Candida bloodstream infectionDetection fungal cellsFiber-Optic Surface Plasmon Resonance (FO-SPR)

Outcome Measures

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.

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

Study Arms (1)

Candidemia

0

Other: Candidemia

Interventions

CandidemiaOTHER
Candidemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients laying in the hospital that suffer from a candidemia.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples

MeSH Terms

Conditions

Candidemia

Condition Hierarchy (Ancestors)

Candidiasis, InvasiveCandidiasisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsFungemiaSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeroen Lammertyn, Prof.

    KU Leuven

    STUDY DIRECTOR

  • Katrien Lagrou, Prof.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2014

First Posted

January 7, 2015

Study Start

June 1, 2016

Primary Completion

December 1, 2017

Last Updated

May 12, 2016

Record last verified: 2015-12