Influenza, HumanNCT01753531
Clinical Performance Study of the Ultra Influenza A&B Test Using Nasal Swabs for Identifying Subjects Who Are Infected With the Influenza Virus Strain Type A or Type B
An observational study of Influenza, Human, run by Sekisui Diagnostics, LLC at 3 sites in United States.
Trial summary
The clinical performance of the Ultra Influenza A\&B Test will be demonstrated during a clinical trial in which prospectively collected nasal swabs are used in identifying subjects who are infected with the influenza virus strain type A or type B. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Flu Symptoms
- Type of treatment
- Medical device
- How many people
- 677 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2012to Jun 2013
- Phase
- Observational
- 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 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects presenting with symptoms suggestive of influenza virus infection will be enrolled from geographically diverse CLIA Waived Intended Users (Physicians office laboratories, clinics or equivalents)
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 (1) presentation within the 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 (2) 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 IRB).
Who cannot join
- The subject underwent a nasal wash/aspirate as part of standard-of-care testing during this study visit.
- The subject is undergoing treatment currently and/or within the past 7 days of the study visit with a nasally administered influenza vaccine (FluMist) or with 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 an experimental biologic, drug or device, including either treatment or therapy.
- The subject has previously participated in this research study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina, 29412
Hill Country Medical Associates
New Braunfels, Texas, 78130
Ardmore Family Practice
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multicenter Performance Evaluation for the Ultra Influenza A&B Test Using Nasal Swabs
The clinical performance of the Ultra Influenza A\&B Test will be demonstrated during a clinical trial in which prospectively collected nasal swabs are used in identifying subjects who are infected with the influenza virus strain type A or type B. The Ultra Influenza A\&B Test qualitative results will be compared to "Gold Standard" viral culture with Direct Fluorescent Antibody (DFA) confirmation techniques using nasal swabs collected from symptomatic subjects. The Ultra Influenza A\&B Test will be performed at Clinical Laboratory Improvement Amendments (CLIA) waived sites by untrained intended users (e.g. nurses, physician assistants, medical assistants, etc.). For viral culture testing with DFA confirmation testing, nasal swab specimen testing will be performed by a designated reference laboratory.
- Conditions
- Influenza, Human
- Being tested
- Flu Symptoms
- Keywords
- Ultra Influenza A and B, Influenza Type A, Influenza Type B, Flu, Sekisui Diagnostics
- 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
| Study group | Role | What they receive |
|---|---|---|
| Flu Symptoms | Not described Receives: Device: Flu Symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify subjects who are infected with the virus strain type A or type B
Characterize the performance of the Ultra Influenza A\&B Test and to identify subjects who are infected with the influenza virus strain type A or type B. Performance data generated will support a 510k submission to FDA for clearance of the assay.
Measured: 6 months
Secondary outcomes (1)
Demonstrate the ability of untrained intended users to effectively run and read the Ultra Influenza A&B Test with insignificant risk of erroneous results.
Demonstrate the ability of untrained intended users to effectively run and read the Ultra Influenza A\&B Test with insignificant risk of erroneous results. Qualitative results obtained using the Ultra Influenza A\&B Test will be compared to viral culture with direct fluorescent antibody (DFA) confirmation testing on specimens collected during this study. Data demonstrating ease of use will support a request to FDA for CLIA waived categorization of the assay.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionJun 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 677 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sekisui Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert D Rosen, MD, Principal investigator, Ardmore Family Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753531
- Sponsor's protocol ID
- CAP-199
- Status last verified
- Jun 2013
- First submitted
- 17 Dec 2012
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Performance Evaluation for the Ultra Influenza A&B Test Using Nasal Swabs
- ClinicalTrials.gov ID
- NCT01753531
- Acronym / sponsor ID
- CAP-199
- Conditions
- Influenza, Human
- Keywords
- Ultra Influenza A and B, Influenza Type A, Influenza Type B, Flu, Sekisui Diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 677 participants (actual)
- Lead sponsor
- Sekisui Diagnostics, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Dec 2012 (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 clinical performance of the Ultra Influenza A\&B Test will be demonstrated during a clinical trial in which prospectively collected nasal swabs are used in identifying subjects who are infected with the influenza virus strain type A or type B. The Ultra Influenza A\&B Test qualitative results will be compared to "Gold Standard" viral culture with Direct Fluorescent Antibody (DFA) confirmation techniques using nasal swabs collected from symptomatic subjects. The Ultra Influenza A\&B Test will be performed at Clinical Laboratory Improvement Amendments (CLIA) waived sites by untrained intended users (e.g. nurses, physician assistants, medical assistants, etc.). For viral culture testing with DFA confirmation testing, nasal swab specimen testing will be performed by a designated reference laboratory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flu Symptoms | – | Device: Flu Symptoms |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects presenting with symptoms suggestive of influenza virus infection will be enrolled from geographically diverse CLIA Waived Intended Users (Physicians office laboratories, clinics or equivalents)
Key inclusion criteria (5 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 (1) presentation within the 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 (2) 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.
Key exclusion criteria (4 listed)
- The subject underwent a nasal wash/aspirate as part of standard-of-care testing during this study visit.
- The subject is undergoing treatment currently and/or within the past 7 days of the study visit with a nasally administered influenza vaccine (FluMist) or with 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 an experimental biologic, drug or device, including either treatment or therapy.
- The subject has previously participated in this research study.
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 Symptoms | Device | Flu Symptoms |
Primary outcome
Identify subjects who are infected with the virus strain type A or type B
Time frame: 6 months
Characterize the performance of the Ultra Influenza A\&B Test and to identify subjects who are infected with the influenza virus strain type A or type B. Performance data generated will support a 510k submission to FDA for clearance of the assay.
1 secondary outcome
Demonstrate the ability of untrained intended users to effectively run and read the Ultra Influenza A&B Test with insignificant risk of erroneous results.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
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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.
Robert D Rosen, MD principal investigator
Ardmore Family Practice
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, Human, run by Sekisui Diagnostics, LLC at 3 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify subjects who are infected with the virus strain type A or type B (time frame: 6 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 24 Jun 2013.