Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel
NCT ID: NCT02547636
Last Updated: 2016-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1822 participants
OBSERVATIONAL
2015-12-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Subjects/specimens that meet the inclusion criteria
Subjects/specimens that meet the inclusion criteria
Observational study
No intervention will be used in this study.
Interventions
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Observational study
No intervention will be used in this study.
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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BioFire Defense LLC
INDUSTRY
BioFire Diagnostics, LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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DX-SDY-020450
Identifier Type: -
Identifier Source: org_study_id