Upper Respiratory InfectionsNCT02232711
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
An observational study of Upper Respiratory Infections, run by BioFire Diagnostics, LLC at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Upper Respiratory Infections
- How many people
- 1,082 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with signs and/or symptoms of respiratory infections
Who may be able to join
- Displays signs and/or symptoms of respiratory infections
- Adult patients must provide informed consent
- Parental consent for children (<18)
Who cannot join
- Adult patients unable to provide informed consent
- Children that are currently in foster care, or are wards of the state
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UTMB Primary Care Pavilion
Galveston, Texas, 77550
South Main Clinic
Salt Lake City, Utah, 84115
Naval Health Research Center
San Diego, California, 92152
Barnes-Jewish/Washington University School of Medicine
St Louis, Missouri, 63103
About this study
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.
- Conditions
- Upper Respiratory Infections
- Keywords
- multiplex, polymerase chain reaction, PCR, BioFire, respiratory infection, infectious disease, point of care, CLIA waived, rapid diagnostics
- Medical subject headings
- Respiratory Tract Infections, Pathologic Complete Response, Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5 hour
Secondary outcomes (1)
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.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,082 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioFire Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232711
- Sponsor's protocol ID
- SDY-014162
- Other IDs
- HDTRA1-09-C0068
- Status last verified
- Jul 2015
- First submitted
- 28 Aug 2014
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10921934Buller RS. Molecular detection of respiratory viruses. Clin Lab Med. 2013 Sep;33(3):439-60. doi: 10.1016/j.cll.2013.03.007.
PubMed 23931834Fairfax 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.
PubMed 24267186
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
- ClinicalTrials.gov ID
- NCT02232711
- Acronym / sponsor ID
- SDY-014162
- Conditions
- Upper Respiratory Infections
- Keywords
- multiplex, polymerase chain reaction, PCR, BioFire, respiratory infection, infectious disease, point of care, CLIA waived, rapid diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,082 participants (actual)
- Lead sponsor
- BioFire Diagnostics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with signs and/or symptoms of respiratory infections
Key inclusion criteria (3 listed)
- Displays signs and/or symptoms of respiratory infections
- Adult patients must provide informed consent
- Parental consent for children (<18)
Key exclusion criteria (2 listed)
- Adult patients unable to provide informed consent
- Children that are currently in foster care, or are wards of the state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness
Time frame: 1.5 hour
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 secondary outcome
Epidemiology of respiratory infections in a CLIA-waived setting
Time frame: Up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
- Background: PubMed 10921934Barenfanger 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.
- Background: PubMed 23931834Buller RS. Molecular detection of respiratory viruses. Clin Lab Med. 2013 Sep;33(3):439-60. doi: 10.1016/j.cll.2013.03.007.
- Background: PubMed 24267186Fairfax 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Respiratory Infections, run by BioFire Diagnostics, LLC at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness (time frame: 1.5 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02232711, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.