InfluenzaNCT01309568
"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"
An observational study of Influenza, run by Quidel Corporation at 16 sites in United States.
Trial summary
The objective of this study is to demonstrate the clinical performance of the Quidel Reader Influenza A+B test and Quidel Reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza
- How many people
- 2,500 participants
- Where
- 16 sitesUnited States
- Study dates
- Feb 2011to Apr 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects current exhibiting influenza like illness.
Who may be able to join
- Male or Female, of all ages (assuming appropriate consent is obtained).
- Must currently be exhibiting symptoms characteristic of influenza-like-illness (ILI).
- For example:
- Fever, ≥ 38º C (100º F), either at the time of the visit or onset within the past two (2) days.
- Nasal congestion
- Rhinorrhea
Show all 11Show fewer
- Sore throat
- Cough
- Headache
- Myalgia
- Malaise
Who cannot join
- Has undergone treatment with anti-influenza antivirals within the previous 7 days, including, for example, one or more of the following, but not be limited to Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.
- Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
- Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Montrose Family Practice
Akron, Ohio, 44333
Dell's Children's Medical Center
Austin, Texas, 78723
La Costa Pediatrics
Carlsbad, California, 92009
Kamakshi Neelkantan, MD
Edgewood, Maryland, 21040
Robert Farron, DO
Far Rockaway, New York, 11691
Paul Janson, MD
Florence, Kentucky, 41042
Priority Care Pediatrics
Kansas City, Missouri, 64155
Adriana Castro, MD
Miami, Florida, 33173
Paul McLaughlin, MD
Mount Sterling, Kentucky, 40353
DuPage Family Medicine
Naperville, Illinois, 60564
Norristown Family Physicians
Norristown, Pennsylvania, 19401
Complete Family Care
Northglenn, Colorado, 80234
Santo Nino Medical Clinic
Panorama City, California, 91402
Twelve Corners Pediatrics
Rochester, New York, 14618
La Jolla Pediatrics
San Diego, California, 92121
Teena Hughes, MD
Tampa, Florida, 33613
About this study
The objective of this study is to demonstrate the clinical performance of the Quidel Reader Influenza A+B test and Quidel Reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or Alternative Laboratory.
Read the detailed description
A sufficient number of subjects will be enrolled to achieve a required minimum of cell culture-positive specimens for each sample type, nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash.
- The 510(k) study will include combined results from all sites and require the following for all three sample types: a minimum of 50 fresh positive results for influenza A, and 30 fresh positive results for influenza B.
- The CLIA Waiver submission will include combined results from all sites for a total of 120 positive specimens for both influenza A and influenza B. The nasal swab will be the primary sample type planned for the CLIA Waiver submission. However, depending upon the prevalence of influenza, nasopharyngeal swab and/or nasopharyngeal aspirate/wash may also be submitted for CLIA Waiver.
- Conditions
- Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Investigational testing | Pending the outcome of culture, the subject may be treated with an approved antiviral medication at the doctors discretion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of infection with influenza
Accurate diagnosis of infection with influenza A or influenza B confirmed by culture
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quidel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John D Tamerius, PhD, Study director, Quidel Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309568
- Sponsor's protocol ID
- CS-0138-01-A
- Status last verified
- May 2011
- First submitted
- 3 Mar 2011
- Last updated
- 12 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"
- ClinicalTrials.gov ID
- NCT01309568
- Acronym / sponsor ID
- CS-0138-01-A
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Quidel CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 7 Mar 2011 (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 objective of this study is to demonstrate the clinical performance of the Quidel Reader Influenza A+B test and Quidel Reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or Alternative Laboratory.
Detailed description
A sufficient number of subjects will be enrolled to achieve a required minimum of cell culture-positive specimens for each sample type, nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash.
- The 510(k) study will include combined results from all sites and require the following for all three sample types: a minimum of 50 fresh positive results for influenza A, and 30 fresh positive results for influenza B.
- The CLIA Waiver submission will include combined results from all sites for a total of 120 positive specimens for both influenza A and influenza B. The nasal swab will be the primary sample type planned for the CLIA Waiver submission. However, depending upon the prevalence of influenza, nasopharyngeal swab and/or nasopharyngeal aspirate/wash may also be submitted for CLIA Waiver.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational testing | – | –Pending the outcome of culture, the subject may be treated with an approved antiviral medication at the doctors discretion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects current exhibiting influenza like illness.
Key inclusion criteria (11 listed)
- Male or Female, of all ages (assuming appropriate consent is obtained).
- Must currently be exhibiting symptoms characteristic of influenza-like-illness (ILI).
- Fever, ≥ 38º C (100º F), either at the time of the visit or onset within the past two (2) days.
- Nasal congestion
- Rhinorrhea
Key exclusion criteria (3 listed)
- Has undergone treatment with anti-influenza antivirals within the previous 7 days, including, for example, one or more of the following, but not be limited to Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.
- Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
- Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of infection with influenza
Time frame: 15 minutes
Accurate diagnosis of infection with influenza A or influenza B confirmed by culture
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 12 May 2011.
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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.
John D Tamerius, PhD study director
Quidel Corporation
16 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, run by Quidel Corporation at 16 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 11 inclusion and 3 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 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Diagnosis of infection with influenza (time frame: 15 minutes). 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 12 May 2011.