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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12609000352202
Ethics application status
Approved
Date submitted
5/05/2009
Date registered
25/05/2009
Date last updated
11/01/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
A study to evaluate a rapid influenza test in subjects presenting to doctors' clinics with influenza like symptoms
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Scientific title
A study to detect the sensitivity and specificity of the Clearview (registered trademark) Influenza A+B Test in subjects presenting with influenza like symptoms
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Secondary ID [1]
288280
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NA
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza
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Condition category
Condition code
Infection
5039
5039
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Subjects presenting with Influenza type symptoms will have nasal swabs tested with the investigational test - Clearview A+B Influenza Test.
The Clearview Influenza A+B Test is an in vitro diagnostic immunochromatographic membrane assay that uses monoclonal antibodies to detect influenza type A and B nucleoprotein antigens in respiratory specimens. These antibodies and a control protein are immobilized onto a membrane support as three distinct lines and are combined with other reagents/pads to construct a test strip.
Samples are added to a reaction tube to which an extraction reagent has been added. A Clearview test strip is then placed in the reaction tube holding the liquid sample. Test results are interpreted at 10 minutes based on the presence or absence of pink-to-purple colored Sample Lines. A blue Control Line indicates a valid test.
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Intervention code [1]
4484
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Diagnosis / Prognosis
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To evaluate the clinical sensitivity and specificity of the Clearview Influenza A+B Test
Outcome will be assessed by comparison of the test result obtained in the clinic with a result tested and obtained by a central laboratory , using standard influenza testing, that will also be testing the same sample.
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Assessment method [1]
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Timepoint [1]
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At time of presentation to doctors clinic
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Secondary outcome [1]
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To demonstrate accuracy of the Clearview Influenza A+B Test in the hands of untrained users in the physician clinic.Outcome will be assessed by comparison of the test result obtained in the clinic with a result tested and obtained by a central laboratory that will also be testing the same sample.
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Assessment method [1]
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Timepoint [1]
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At time of presentation to doctors clinic
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Eligibility
Key inclusion criteria
presented to clinic with 2 of the following symptoms: fever, headache, extreme tiredness, dry cough, sore throat, runny or stuffy nose, muscle aches AND/OR participant is suspected of having influenza.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Received a nasal vaccine within the last 5 days, or currently taking an antiviral medication for influenza within the past 30 days.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/05/2009
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Actual
10/08/2009
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Date of last participant enrolment
Anticipated
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Actual
29/08/2009
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
750
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Accrual to date
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Final
750
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Rotorua
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Country [2]
1749
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New Zealand
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State/province [2]
1749
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Christchurch
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Country [3]
1750
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New Zealand
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State/province [3]
1750
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Dunedin
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Inverness Medical (IMI)
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Address [1]
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10 Southgate Road
Scarborough, ME 04074
USA
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Inverness Medical (IMI)
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Address
10 Southgate Road
Scarborough, ME 04074
USA
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
4430
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Address [1]
4430
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Country [1]
4430
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Multi Region Ethics Committee
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Ethics committee address [1]
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1-3 The Terrace, Wellington 6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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01/05/2009
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Approval date [1]
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10/06/2009
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Ethics approval number [1]
6961
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Summary
Brief summary
Approximately 750 subjects, presenting with flu-like symptoms, will be prospectively enrolled and samples (nasal swab samples) will be collected from consecutive patients.
All subjects will be assigned a unique subject identification (ID) number in sequential order as they are enrolled into the study. Each site will collect two nasal swabs from each subject.
Clearview testing of patient samples will be conducted by more than one operator, and the testing will be equally distributed among the operators at each site.
The 3 New Zealand (NZ) sites will be classified as “untrained user” sites and will receive no formal training on the performance and interpretation of the investigational device. No additional written procedures beyond the information contained within the protocol and the written test procedure will be provided. The test operators at the “untrained user” sites will be provided with an operator questionnaire at the conclusion of enrollment at that site.
All specimens will be tested with the Clearview (registered trademark) Influenza A+B Test according to product instructions, and will be sent to a clinical laboratory for viral culture
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Trial website
None
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Trial related presentations / publications
None available
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Public notes
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Contacts
Principal investigator
Name
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Dr Dr Mike WIlliams
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Address
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Hinemoa House Medical Centre, 1271 Hinemoa Street, Rotorua 3010
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Country
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New Zealand
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Phone
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+ 64 7 348 3002
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Dr Mike Williams
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Address
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Hinemoa House Medical Centre,
1271 Hinemoa Street,
Rotorua 3010
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Country
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New Zealand
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Phone
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+ 64 7 348 3002
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Dr Mike Williams
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Address
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Hinemoa House Medical Centre,
1271 Hinemoa Street,
Rotorua 3010
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Country
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New Zealand
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Phone
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+ 64 7 348 3002
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Fax
3742
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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