Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel
1 other identifier
observational
1,822
1 country
6
Brief Summary
This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 21, 2016
December 1, 2016
1 year
September 10, 2015
December 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical specificity of the FilmArray NGDS Warrior Panel
8 months
Study Arms (1)
Subjects/specimens that meet the inclusion criteria
Subjects/specimens that meet the inclusion criteria
Interventions
No intervention will be used in this study.
Eligibility Criteria
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.
You may qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioFire Diagnostics, LLClead
- BioFire Defense LLCcollaborator
Study Sites (6)
Navy Medical Center San Diego/Naval Health Research Center
San Diego, California, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Washington University/Barnes Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Biospecimen
Residual specimens may be stored for use as negative clinical matrix in contrived testing studies.
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2015
First Posted
September 11, 2015
Study Start
December 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
December 21, 2016
Record last verified: 2016-12