Clinical trial NCT02996136: Assessment of the Clinical Performance of the ARROW-FLU System
Official title: Assessment of the Clinical Performance of the ARROW-FLU System for the Detection of Influenza A and B in Symptomatic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Influenza, Human
Lead sponsor: Sekisui Diagnostics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Beaufort CRO
First posted: 2016-12-19
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The ARROW-FLU Influenza A\&B Test is an in vitro diagnostic immuno-chromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal or nasopharyngeal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture of an FDA cleared molecular device. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

Detailed description: This multicenter prospective study will include nasal and nasopharyngeal swabs collected from patients who present with flu-like symptoms and have undergone routine testing for influenza virus strain types A or B. The ARROW-FLU Influenza A\&B Test System qualitative results will be compared to a reference method for identification of Influenza A or B to determine the clinical sensitivity and specificity of the device.

The ARROW-FLU Influenza A\&B Test system will be performed at CLIA-waived and non-CLIA waived clinical sites. Device operators at CLIA-waived sites will be untrained intended users (e.g. nurses, physician assistants, medical assistants, etc).

A subject's participation in this study will consist of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number. After standard of care sampling, two (2) nasal or nasopharyngeal swabs will be obtained from each subject enrolled in the study. The swabs will be collected from the same nostril and alternated in their order of designation for testing (i.e. one for ARROW-FLU Influenza System testing and the other for reference testing. Any swab specimens required for standard of care testing will be collected prior to the specimens for this investigation. Investigational device operators will be blinded to standard of care testing results.

Eligibility criteria: Inclusion Criteria:

1. The subject may be of any age and either gender.
2. Preliminary assessment of the subject by the Investigator/Designee should be suggestive of influenza virus infection. Subject should present with an influenza-like febrile respiratory illness defined as both

   * Presentation within that last 48 hours of developing a subjective feeling of being feverish and/or a temperature recorded at the clinic within the last 48 hours of greater than or equal to 100.5 F and
   * At least two of the following symptoms: cough, nasal congestion, rhinorrhea, sore throat, headache, myalgia.
3. Written informed consent must be obtained prior to study enrollment:

   1. A subject who is 18 years or older must be willing to give written informed consent and must agree to comply with study procedures.
   2. The legal authorized representative of a subject who is under the age of 18 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as defined by the clinical site's IRB).

Exclusion Criteria:

1. The subject underwent a nasal wash/aspirate as part of standard-of-care (SOC) testing during this study visit.
2. The subject is undergoing treatment currently or within the past seven (7) days of the study visit with either

   * A nasally-administered influenza vaccine (FluMist)
   * Anti-viral medication, which may include but is not limited to Amantadine (Symmetrel), Rimantadine (Flumadine), Zanamivir (Relenza), Oseltamivir (Tamiflu), or Ribavirin.
3. The subject is currently receiving or has received within the past thirty (30) days of the study visit anu experimental biologic, drug, or device including either treatment or therapy.

Primary outcomes:
measure: Performance of the ARROW-FLU Influenza Test
timeFrame: Through study completion, an average of 5 months
Secondary outcomes:
measure: Ability of untrained intended users to effectively perform the ARROW-FLU Influenza Test
timeFrame: Through study completion, an average of 5 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Crowley
country: United States
facility: Avant Research Associates LLC
state: Louisiana
city: North Attleboro
country: United States
facility: Tristan Medical Research Center / Regeneris Medical
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy
state: Missouri
city: Las Vegas
country: United States
facility: Accent Clinical Vegas
state: Nevada
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions LLC (Ohio)
state: Ohio
city: Smyrna
country: United States
facility: Clinical Research Solutions LLC (Tennessee)
state: Tennessee
city: Eau Claire
country: United States
facility: Marshfield Clinic
state: Wisconsin
Study officials:
affiliation: Sekisui Diagnostics, LLC
name: Daiva Schmidt
role: STUDY_DIRECTOR
References: