Status:
COMPLETED
Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel
Lead Sponsor:
BioFire Diagnostics, LLC
Conditions:
Lower Resp Tract Infection
Eligibility:
All Genders
Brief Summary
This is a performance study to test the sensitivity and specificity of the BioFire FilmArray Lower Respiratory Tract Infection (LRTI) Panel. The purpose of this study is to prospectively collect and t...
Detailed Description
BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray. The FilmArray Lower Respira...
Eligibility Criteria
Inclusion
- Specimen is residual LRT specimen (sputum, ETA, BAL, or mini-BAL) that was submitted under clinician order for standard care LRT testing
- Specimen has not been centrifuged
- Specimen has not been pre-treated
- Specimen has at least 1.5 mL of residual volume
- Specimen was collected from a subject not already enrolled in the study
- Specimen is fresh (stored at \~4°C, not frozen) and was enrolled with 24 hours of collection
Exclusion
- Specimen was centrifuged, pre-treated, or is less than 1.5mL
- Specimen was collected from a subject known to have cystic fibrosis
- Specimen was collected from a subject known to have tuberculosis
- Specimen was collected from a subject that was previously enrolled in the study
- Specimen has been stored for longer than 24 hours, or was frozen, or stored at room temperature for longer than 4 hours.
Key Trial Info
Start Date :
October 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
1689 Patients enrolled
Trial Details
Trial ID
NCT03361670
Start Date
October 1 2016
End Date
July 1 2017
Last Update
December 5 2017
Active Locations (8)
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1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
3
Loyola University Medical Center
Maywood, Illinois, United States, 60153
4
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202