Bio-assay Development and Implementation for Fungal Infec... | NCT02333266

Studies
Bio-assay Development and Implementation for Fungal Infection Detection

NCT02333266

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Withdrawn

Last Update Posted

May 12, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Candidemia

Interventions

Candidemia

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The bioassay development is too difficult.

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Not provided

First Submitted Date

Dec 17, 2014

First Submission Date that Met QC Criteria

Jan 5, 2015

First Posted Date

Jan 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2016

Last Update Posted Date

May 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Label	Type	Description	Intervention Names
Candidemia		0	Other: Candidemia

Name	Type	Description	Arm Group Labels	Other Names
Candidemia	Other		Candidemia

Outcomes Module

Primary Outcomes

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	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients laying in the hospital that suffer from a candidemia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeroen Lammertyn, Prof.	KU Leuven	Study Director
Katrien Lagrou, Prof.	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058387	Candidemia

Ancestor Terms

ID	Term
D058365	Candidiasis, Invasive
D002177	Candidiasis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

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Browse Branches

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