InfluenzaNCT00491283
QuickVue Influenza A+B Clinical Field Trial
A study testing Swab Specimen Collection (QuickVue) in people with Influenza, run by Quidel Corporation at 1 site in Australia.
Trial summary
A comparative study of different swab types used for collection of specimens for rapid inluenza testing Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza
- What is being tested?
- Swab Specimen Collection (QuickVue)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteAustralia
- Study dates
- Jul 2006to Aug 2006
- 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
- Subjects must have:
- Fever (>38°C) (at time of visit or within the previous 48 hrs by history) and at least two of the following symptoms:
- Chills/sweats
- Cough
- Dyspnea (labored, difficult breathing)
- Fatigue
Show all 11Show fewer
- Headache
- Myalgia (deep muscle aches)
- Nasal congestion
- Runny nose
- Sore throat
Who cannot join
- Patients who are undergoing treatment with antivirals, now or within the last 7 days cannot be included in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Swab Types for Specimen Collection
A comparative study of different swab types used for collection of specimens for rapid inluenza testing
- Conditions
- Influenza
- Being tested
- Swab Specimen Collection (QuickVue)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swab Specimen Collection (QuickVue)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Measured: five months
Secondary outcomes (1)
Sensitivity and Specificity
Measured: Positive and Negative Predictive Values
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startJul 2006
- Primary completionAug 2006
- Study completionAug 2006
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Quidel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew Keller, MD, Principal investigator, Sydney Airport medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491283
- Sponsor's protocol ID
- CS-0119-08(B)
- Status last verified
- Jan 2008
- First submitted
- 22 Jun 2007
- Last updated
- 28 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Swab Types for Specimen Collection
- ClinicalTrials.gov ID
- NCT00491283
- Acronym / sponsor ID
- CS-0119-08(B)
- Conditions
- Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Quidel CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 26 Jun 2007 (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.
A comparative study of different swab types used for collection of specimens for rapid inluenza testing
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Fever (>38°C) (at time of visit or within the previous 48 hrs by history) and at least two of the following symptoms:
Key exclusion criteria (1 listed)
- Patients who are undergoing treatment with antivirals, now or within the last 7 days cannot be included in this 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 |
|---|---|---|
| Swab Specimen Collection (QuickVue) | Device | – |
Primary outcome
Sensitivity and Specificity
Time frame: five months
1 secondary outcome
Sensitivity and Specificity
Time frame: Positive and Negative Predictive Values
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 28 Jan 2008.
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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.
Andrew Keller, MD principal investigator
Sydney Airport medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swab Specimen Collection (QuickVue) in people with Influenza, run by Quidel Corporation at 1 site in Australia.
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 1 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 28 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
Sensitivity and Specificity (time frame: five 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 28 Jan 2008.