Assessment of the Clinical Performance of the ARROW-FLU System

NCT02996136 | Unknown

• 1 other identifier: FLU-001-15
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 14

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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (1)

• Performance of the ARROW-FLU Influenza Test

  The primary objective of this study is the characterization of the performance of the ARROW-FLU Influenza Test to detect influenza virus strain type A or type B in symptomatic subjects. Qualitative results obtained using the ARROW-FLU Influenza Test will be compared to a reference method or "Gold Standard" (viral culture and/or an FDA cleared molecular assay). Performance data generated will support a 510k submission to FDA for clearance of the assay.

  Through study completion, an average of 5 months

Secondary Outcomes (1)

• Ability of untrained intended users to effectively perform the ARROW-FLU Influenza Test

  Through study completion, an average of 5 months

Study Arms (2)

Nasal Swab

EXPERIMENTAL

Nasal Swab

Device: Flu Symptoms

Nasopharyngeal Swab

EXPERIMENTAL

Nasopharyngeal Swab

Device: Flu Symptoms

Interventions

Flu Symptoms DEVICE

Flu Symptoms

Nasal Swab; Nasopharyngeal Swab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject may be of any age and either gender.
• 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.
• Written informed consent must be obtained prior to study enrollment:
• A subject who is 18 years or older must be willing to give written informed consent and must agree to comply with study procedures.
• 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).

You may not qualify if:

• The subject underwent a nasal wash/aspirate as part of standard-of-care (SOC) testing during this study visit.
• 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.
• 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.

Sponsors & Collaborators

• Sekisui Diagnostics, LLC: lead
• Beaufort CRO: collaborator

Study Sites (14)

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Sunrise Medical Research

Lauderdale Lakes, Florida, 33319, United States

Location

Sacred Heart Hospital

Pensacola, Florida, 32504, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Avant Research Associates LLC

Crowley, Louisiana, 70526, United States

Location

Tristan Medical Research Center / Regeneris Medical

North Attleboro, Massachusetts, 02760, United States

Location

Children's Mercy

Kansas City, Missouri, 64108, United States

Location

Accent Clinical Vegas

Las Vegas, Nevada, 89104, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Clinical Research Solutions LLC (Ohio)

Middleburg Heights, Ohio, 44130, United States

Location

Clinical Research Solutions LLC (Tennessee)

Smyrna, Tennessee, 37167, United States

Location

Marshfield Clinic

Eau Claire, Wisconsin, 54701, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Daiva Schmidt

  Sekisui Diagnostics, LLC

  STUDY DIRECTOR

Central Study Contacts

Steven Grossman

CONTACT

781-652-7828; steven.grossman@sekisuidiagnostics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 19, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: December 19, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)