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Assessment of the Clinical Performance of the ARROW-FLU System

Primary Purpose

Influenza, Human

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flu Symptoms
Sponsored by
Sekisui Diagnostics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Influenza, Human

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Applied Research Center of Arkansas
  • Clinical Research of South Florida
  • Sunrise Medical Research
  • Sacred Heart Hospital
  • Indiana University School of Medicine
  • University of Iowa
  • Avant Research Associates LLC
  • Tristan Medical Research Center / Regeneris Medical
  • Children's Mercy
  • Accent Clinical Vegas
  • Wake Research Associates
  • Clinical Research Solutions LLC (Ohio)
  • Clinical Research Solutions LLC (Tennessee)
  • Marshfield Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nasal Swab

Nasopharyngeal Swab

Arm Description

Nasal Swab

Nasopharyngeal Swab

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Ability of untrained intended users to effectively perform the ARROW-FLU Influenza Test
The secondary objective of this study is to demonstrate the ability of untrained intended users to effectively perform the ARROW-FLU Influenza A&B Test with insignificant risk of erroneous results. Qualitative results obtained using the ARROW-FLU Influenza Test System will be compared to the reference method for confirmation of results on specimens collected during this study.

Full Information

First Posted
December 12, 2016
Last Updated
December 14, 2016
Sponsor
Sekisui Diagnostics, LLC
Collaborators
Beaufort CRO
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1. Study Identification

Unique Protocol Identification Number
NCT02996136
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sekisui Diagnostics, LLC
Collaborators
Beaufort CRO

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasal Swab
Arm Type
Experimental
Arm Description
Nasal Swab
Arm Title
Nasopharyngeal Swab
Arm Type
Experimental
Arm Description
Nasopharyngeal Swab
Intervention Type
Device
Intervention Name(s)
Flu Symptoms
Intervention Description
Flu Symptoms
Primary Outcome Measure Information:
Title
Performance of the ARROW-FLU Influenza Test
Description
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.
Time Frame
Through study completion, an average of 5 months
Secondary Outcome Measure Information:
Title
Ability of untrained intended users to effectively perform the ARROW-FLU Influenza Test
Description
The secondary objective of this study is to demonstrate the ability of untrained intended users to effectively perform the ARROW-FLU Influenza A&B Test with insignificant risk of erroneous results. Qualitative results obtained using the ARROW-FLU Influenza Test System will be compared to the reference method for confirmation of results on specimens collected during this study.
Time Frame
Through study completion, an average of 5 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Grossman
Phone
781-652-7828
Email
steven.grossman@sekisuidiagnostics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daiva Schmidt
Organizational Affiliation
Sekisui Diagnostics, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Applied Research Center of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Simpson, MD
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Rosen, MD
Facility Name
Sunrise Medical Research
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Haffizulla, MD
Facility Name
Sacred Heart Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Mayne, BS (MT) ASCP
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Davis, MD, PhD
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana King, MD
Facility Name
Avant Research Associates LLC
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satinder Saini, MD
Facility Name
Tristan Medical Research Center / Regeneris Medical
City
North Attleboro
State/Province
Massachusetts
ZIP/Postal Code
02760
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Welter, MD
Facility Name
Children's Mercy
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rangaraj Selvarangan, PhD
Facility Name
Accent Clinical Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rogelio Machuca, MD
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wayne Harper, MD
Facility Name
Clinical Research Solutions LLC (Ohio)
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Panuto, MD
Facility Name
Clinical Research Solutions LLC (Tennessee)
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sadia Dar, MD
Facility Name
Marshfield Clinic
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Kyle, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of the Clinical Performance of the ARROW-FLU System

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