Influenza, HumanNCT02996136
Assessment of the Clinical Performance of the ARROW-FLU System
A study testing Flu Symptoms in people with Influenza, Human, run by Sekisui Diagnostics, LLC at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Flu Symptoms
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 14 sitesUnited States
- Study dates
- Dec 2016to Apr 2017
- Phase
- Interventional
- 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
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Clinical Research of South Florida
Coral Gables, Florida, 33134
Jeffrey Rosen, MD
Avant Research Associates LLC
Crowley, Louisiana, 70526
Satinder Saini, MD
Marshfield Clinic
Eau Claire, Wisconsin, 54701
Julia Kyle, MD
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Thomas Davis, MD, PhD
University of Iowa
Iowa City, Iowa, 52242
Dana King, MD
Children's Mercy
Kansas City, Missouri, 64108
Rangaraj Selvarangan, PhD
Accent Clinical Vegas
Las Vegas, Nevada, 89104
Rogelio Machuca, MD
Sunrise Medical Research
Lauderdale Lakes, Florida, 33319
Jason Haffizulla, MD
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Steve Simpson, MD
Clinical Research Solutions LLC (Ohio)
Middleburg Heights, Ohio, 44130
John Panuto, MD
Tristan Medical Research Center / Regeneris Medical
North Attleboro, Massachusetts, 02760
Ryan Welter, MD
Sacred Heart Hospital
Pensacola, Florida, 32504
Donna Mayne, BS (MT) ASCP
Wake Research Associates
Raleigh, North Carolina, 27612
Wayne Harper, MD
Clinical Research Solutions LLC (Tennessee)
Smyrna, Tennessee, 37167
Sadia Dar, MD
About this study
Official title: Assessment of the Clinical Performance of the ARROW-FLU System for the Detection of Influenza A and B in Symptomatic Patients
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.
Read the 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.
- Conditions
- Influenza, Human
- Being tested
- Flu Symptoms
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu SymptomsDevice
Flu Symptoms
| Study group | Role | What they receive |
|---|---|---|
| Nasal Swab | Experimental | Nasal Swab Receives: Device: Flu Symptoms |
| Nasopharyngeal Swab | Experimental | Nasopharyngeal Swab Receives: Device: Flu Symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 5 months
Secondary outcomes (1)
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.
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sekisui Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beaufort CRO
- Responsible party
- Sponsor
- Investigators
- Daiva Schmidt, Study director, Sekisui Diagnostics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996136
- Sponsor's protocol ID
- FLU-001-15
- Status last verified
- Dec 2016
- First submitted
- 12 Dec 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Clinical Performance of the ARROW-FLU System for the Detection of Influenza A and B in Symptomatic Patients
- ClinicalTrials.gov ID
- NCT02996136
- Acronym / sponsor ID
- FLU-001-15
- Conditions
- Influenza, Human
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Sekisui Diagnostics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Beaufort CRO
- Study start
- Dec 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 19 Dec 2016 (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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Swab | Experimental | Device: Flu SymptomsNasal Swab |
| Nasopharyngeal Swab | Experimental | Device: Flu SymptomsNasopharyngeal Swab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Written informed consent must be obtained prior to study enrollment:
Key exclusion criteria (5 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flu SymptomsFlu Symptoms | Device | Nasal Swab, Nasopharyngeal Swab |
Primary outcome
Performance of the ARROW-FLU Influenza Test
Time frame: Through study completion, an average of 5 months
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.
1 secondary outcome
Ability of untrained intended users to effectively perform the ARROW-FLU Influenza Test
Time frame: Through study completion, an average of 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Daiva Schmidt study director
Sekisui Diagnostics, LLC
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flu Symptoms in people with Influenza, Human, run by Sekisui Diagnostics, LLC at 14 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven Grossman (781-652-7828, steven.grossman@sekisuidiagnostics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the ARROW-FLU Influenza Test (time frame: Through study completion, an average of 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2016.