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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02232711
Other study ID # SDY-014162
Secondary ID HDTRA1-09-C0068
Status Completed
Phase N/A
First received August 28, 2014
Last updated July 23, 2015
Start date November 2014
Est. completion date July 2015

Study information

Verified date July 2015
Source BioFire Diagnostics, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's instructions by personnel in laboratories holding Clinical Laboratory Improvement Amendments (CLIA) waivers (or equivalent) on nasopharyngeal swab samples obtained from volunteers with signs and/or symptoms of a respiratory infection. The study data will be used to support an application to the FDA for CLIA-waived categorization of FilmArray RP EZ. It is hypothesized that the results of the FilmArray RP EZ test performed in a laboratory with CLIA waiver with be 95% accurate when compared to FilmArray RP testing performed in a lab with a moderate or high complexity CLIA certification.


Recruitment information / eligibility

Status Completed
Enrollment 1082
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Displays signs and/or symptoms of respiratory infections

- Adult patients must provide informed consent

- Parental consent for children (<18)

Exclusion Criteria:

- Adult patients unable to provide informed consent

- Children that are currently in foster care, or are wards of the state

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
United States UTMB Primary Care Pavilion Galveston Texas
United States South Main Clinic Salt Lake City Utah
United States Naval Health Research Center San Diego California
United States Barnes-Jewish/Washington University School of Medicine St. Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
BioFire Diagnostics, LLC United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (3)

Barenfanger J, Drake C, Leon N, Mueller T, Troutt T. Clinical and financial benefits of rapid detection of respiratory viruses: an outcomes study. J Clin Microbiol. 2000 Aug;38(8):2824-8. — View Citation

Buller RS. Molecular detection of respiratory viruses. Clin Lab Med. 2013 Sep;33(3):439-60. doi: 10.1016/j.cll.2013.03.007. Review. — View Citation

Fairfax MR, Salimnia H. Diagnostic molecular microbiology: a 2013 snapshot. Clin Lab Med. 2013 Dec;33(4):787-803. doi: 10.1016/j.cll.2013.08.003. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness In general, performance of the FilmArray RP EZ test in the CLIA-waived setting is expected to meet at least 95% positive and negative percent agreement with the results obtained from FilmArray RP in the moderate/high- complexity setting for each pathogen on the panel. 1.5 hour No
Secondary Epidemiology of respiratory infections in a CLIA-waived setting Seasonality and rate of respiratory infection at each of the CLIA-waived sites using the FilmArray RP EZ to collect prospectively enrolled specimens will be evaluated at the end of the study. Up to 9 months No
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