Influenza A, Influenza BQuickVue FluNCT03417869
QuickVue Influenza A + B Test Field Study
An observational study of Influenza A, Influenza B, run by Quidel Corporation at 5 sites in United States.
Trial summary
Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza A, Influenza B
- What is being tested?
- QuickVue Influenza A+B
- Type of treatment
- Medical device
- How many people
- 1,381 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Feb 2017to 1 Feb 2018
- 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 will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza
Who may be able to join
- Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza. They must meet the following criteria to be eligible for enrollment:
- Male or Female of all ages (with appropriate consent).
- The subject must have had of a fever, ≥ 37.8º C (100º F), within the last two days.
- Must also be currently exhibiting one or more of the following symptoms characteristic of influenza-like-illness (ILI).
- Nasal congestion
- Rhinorrhea
Show all 11Show fewer
- Sore throat
- Cough
- Headache
- Myalgia
- Malaise
Who cannot join
- 1. Has undergone treatment with anti-influenza antivirals within the previous 7 days, to include but not be limited to, Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.
- 2. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
- 3. Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Veritas, P.A.
Belton, Texas, 76513
City Doc Urgent Care
Dallas, Texas, 75209
Alliance Urgent Care
Phoenix, Arizona, 85353
Twelve Corners Pediatrics
Rochester, New York, 14618
Advanced Pediatrics
Vienna, Virginia, 22180
About this study
Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test.
Read the detailed description
The objective of this study is to demonstrate an improved clinical performance of the visually read QuickVue Influenza A+B test with nasal and nasopharyngeal swab specimens. Clinical performance will be based on comparison of QuickVue results to either cell culture or an FDA-cleared molecular test at one or more Reference Laboratories.
- Conditions
- Influenza A, Influenza B
- Being tested
- QuickVue Influenza A+B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuickVue Influenza A+BDevice
Rapid diagnostic test with IVD, QuickVue Influenza A+B
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza Diagnostic test result
rapid IVD test
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start16 Feb 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza A, Influenza BStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quidel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417869
- Sponsor's protocol ID
- CS-0103-02
- Acronym
- QuickVue Flu
- Status last verified
- Mar 2018
- First submitted
- 24 Jan 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QuickVue Influenza A + B Test Field Study
- ClinicalTrials.gov ID
- NCT03417869
- Acronym / sponsor ID
- QuickVue Flu / CS-0103-02
- Conditions
- Influenza A, Influenza B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,381 participants (actual)
- Lead sponsor
- Quidel CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 31 Jan 2018 (actual)
- 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.
Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test.
Detailed description
The objective of this study is to demonstrate an improved clinical performance of the visually read QuickVue Influenza A+B test with nasal and nasopharyngeal swab specimens. Clinical performance will be based on comparison of QuickVue results to either cell culture or an FDA-cleared molecular test at one or more Reference Laboratories.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza
Key inclusion criteria (11 listed)
- Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza. They must meet the following criteria to be eligible for enrollment:
- Male or Female of all ages (with appropriate consent).
- The subject must have had of a fever, ≥ 37.8º C (100º F), within the last two days.
- Must also be currently exhibiting one or more of the following symptoms characteristic of influenza-like-illness (ILI).
Key exclusion criteria (3 listed)
- 1. Has undergone treatment with anti-influenza antivirals within the previous 7 days, to include but not be limited to, Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.
- 2. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
- 3. 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuickVue Influenza A+BRapid diagnostic test with IVD, QuickVue Influenza A+B | Device | – |
Primary outcome
Influenza Diagnostic test result
Time frame: 10 minutes
rapid IVD test
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 20 Mar 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 A, Influenza B, run by Quidel Corporation at 5 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Influenza Diagnostic test result (time frame: 10 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 20 Mar 2018.