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
213 participants
OBSERVATIONAL
2015-11-30
2016-10-31
Brief Summary
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Detailed Description
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This clinical study will collect data in support of regulatory submission and the indications for use of the IFV-RSV panel and the Idylla diagnostic system. This protocol will demonstrate that the results of this assay, in conjunction with clinical information, may be used as an aid in the diagnosis of infection with Influenza A, Influenza B, and RSV in persons having both a high and low risk for respiratory viral infection.
During this study, participating sites will collect fresh samples, conduct a Reproducibility Study and test the fresh and previously collected frozen samples from individuals presenting with signs/symptoms of influenza like illness (ILI) and respiratory virus in accordance to the sample collection described in this protocol.
Conditions
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Study Design
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CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* All Ages
* Subject, or legally authorized representative, has provided IRB/EC approved written Informed Consent, privacy (e.g. HIPAA) authorization when required and Assent where applicable prior to any study-related procedure(s) being performed
* Patient presenting with ILI and/or Signs/Symptoms of RSV Infection as defined in this protocol
* Onset of ILI and/or Signs/Symptoms of RSV Infection was ≤ 5 days prior to subject screening (Refer to the definitions for detailed descriptions of ILI and Signs/Symptoms of RSV infection)
* Clinician's determination that illness is due to a viral infection
* Subject agrees to allow study specimens to be used for future studies
Exclusion Criteria
* Subject received live intranasal attenuated influenza virus in last 3 weeks (e.g. FluMist, Fluenz)
* Subject received treatment with influenza directed antiviral (e.g. Zanamivir, oseltamivir (Tamiflu), amantadine, rimantadine) in the last 5 days
* The subject was previously enrolled in this study
* Clinician's determination that illness is NOT due to a viral infection (e.g. allergies)
* Subject had a nasal wash within last 8 hours. This exclusion includes any extraction of nasal secretions by nasal suctioning with fluid
* Subject does not agree to allow study specimens to be used for future research studies
ALL
No
Sponsors
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Janssen Pharmaceutica N.V., Belgium
INDUSTRY
Responsible Party
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Principal Investigators
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Theresa Pattery, MD
Role: STUDY_DIRECTOR
Janssen Diagnostics
Locations
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Sacred Heart Hospital - Pensacola
Pensacola, Florida, United States
Countries
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Other Identifiers
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CODX0006NAP3001
Identifier Type: -
Identifier Source: org_study_id