Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel

December 19, 2016 updated by: BioFire Diagnostics, LLC
This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1822

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States
        • Navy Medical Center San Diego/Naval Health Research Center
    • Hawaii
      • Honolulu, Hawaii, United States
        • Tripler Army Medical Center
    • Missouri
      • St. Louis, Missouri, United States
        • Washington University/Barnes Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States
        • University of Nebraska Medical Center
    • Ohio
      • Columbus, Ohio, United States
        • Ohio State University Medical Center
    • Washington
      • Tacoma, Washington, United States
        • Madigan Army Medical Center

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

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
Subjects/specimens that meet the inclusion criteria
Other: Observational study
No intervention will be used in this study.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

BioFire Diagnostics, LLC

Collaborators

BioFire Defense LLC

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

December 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (ESTIMATE)

September 11, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • DX-SDY-020450

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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