Prospective Clinical Evaluation of the FilmArray® NGDS Wa... | NCT02547636

Studies
Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel

NCT02547636

Sponsor

BioFire Diagnostics, LLC

Status

Completed

Last Update Posted

Dec 21, 2016Estimated

Enrollment

1,822Actual

Phase

Not provided

Conditions

Evaluation of Test Panel

Interventions

Observational study

Countries

United States

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 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Sep 10, 2015

First Submission Date that Met QC Criteria

Sep 10, 2015

First Posted Date

Sep 11, 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

Dec 19, 2016

Last Update Posted Date

Dec 21, 2016Estimated

Name	Class
BioFire Defense LLC	INDUSTRY

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

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

1,822Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects/specimens that meet the inclusion criteria		Subjects/specimens that meet the inclusion criteria	Other: Observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational study	Other	No intervention will be used in this study.	Subjects/specimens that meet the inclusion criteria

Measure	Description	Time Frame
Clinical specificity of the FilmArray NGDS Warrior Panel		8 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Whole blood (prospectively collected via informed consent):
Adult subject has a recorded or self-reported fever within the previous 24 hours
Subject provides informed consent prior to enrollment and specimen collection
Subject has not previously provided a whole blood specimen for this study

Whole blood (residual)

Whole blood (in EDTA) submitted to laboratory for standard of care testing
Specimen is not from an individual with a specimen previously enrolled in the study

Positive Blood Culture:

Culture was detected as positive by an automated blood culture system
Culture is not from a patient previously enrolled in the study

Negative Blood Culture:

Culture not detected as positive by an automated blood culture system
Culture is not from a patient previously enrolled in the study

Sputum:

Specimen was accepted for testing by the respective site's microbiology laboratory
Specimen is not from an individual that has a sputum already enrolled in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects with fever will be prospectively enrolled, and whole blood will be collected. Additional residual specimens left-over from standard of care laboratory testing will also be enrolled.

Sampling Method

Non-Probability Sample

ID	Term
D008722	Methods
D008919	Investigative Techniques