NCT02232711

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,082

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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

August 28, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

8 months

First QC Date

August 28, 2014

Last Update Submit

July 23, 2015

Conditions

Upper Respiratory Infections

Keywords

multiplex, polymerase chain reaction, PCR, BioFire, respiratory infection, infectious disease, point of care, CLIA waived, rapid diagnostics

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Epidemiology of respiratory infections in a CLIA-waived setting

    Up to 9 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with signs and/or symptoms of respiratory infections

You may qualify if:

  • Displays signs and/or symptoms of respiratory infections
  • Adult patients must provide informed consent
  • Parental consent for children (\<18)

You may not qualify if:

  • Adult patients unable to provide informed consent
  • Children that are currently in foster care, or are wards of the state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Naval Health Research Center

San Diego, California, 92152, United States

Location

Barnes-Jewish/Washington University School of Medicine

St Louis, Missouri, 63103, United States

Location

UTMB Primary Care Pavilion

Galveston, Texas, 77550, United States

Location

South Main Clinic

Salt Lake City, Utah, 84115, United States

Location

Related 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. doi: 10.1128/JCM.38.8.2824-2828.2000.

    PMID: 10921934BACKGROUND

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

    PMID: 23931834BACKGROUND

  • 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.

    PMID: 24267186BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab (NPS) specimens

MeSH Terms

Conditions

Respiratory Tract InfectionsPathologic Complete ResponseCommunicable Diseases

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 5, 2014

Study Start

November 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 24, 2015

Record last verified: 2015-07

Locations

US(4)