Trial Review

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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
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
Secondary ID [1] 288280 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 4717 0
Condition category
Condition code
Infection 5039 5039 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 4484 0
Diagnosis / Prognosis
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5879 0
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.
Timepoint [1] 5879 0
At time of presentation to doctors clinic
Secondary outcome [1] 241911 0
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.
Timepoint [1] 241911 0
At time of presentation to doctors clinic

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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2009
Actual
10/08/2009
Date of last participant enrolment
Anticipated
Actual
29/08/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
750
Accrual to date
Final
750
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 1748 0
New Zealand
State/province [1] 1748 0
Rotorua
Country [2] 1749 0
New Zealand
State/province [2] 1749 0
Christchurch
Country [3] 1750 0
New Zealand
State/province [3] 1750 0
Dunedin

Funding & Sponsors
Funding source category [1] 4898 0
Commercial sector/Industry
Name [1] 4898 0
Inverness Medical (IMI)
Country [1] 4898 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Inverness Medical (IMI)
Address
10 Southgate Road
Scarborough, ME 04074
USA
Country
United States of America
Secondary sponsor category [1] 4430 0
None
Name [1] 4430 0
Address [1] 4430 0
Country [1] 4430 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6961 0
Multi Region Ethics Committee
Ethics committee address [1] 6961 0
Ethics committee country [1] 6961 0
New Zealand
Date submitted for ethics approval [1] 6961 0
01/05/2009
Approval date [1] 6961 0
10/06/2009
Ethics approval number [1] 6961 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29567 0
Dr Dr Mike WIlliams
Address 29567 0
Hinemoa House Medical Centre, 1271 Hinemoa Street, Rotorua 3010
Country 29567 0
New Zealand
Phone 29567 0
+ 64 7 348 3002
Fax 29567 0
Email 29567 0
mwilliams@rgpg.co.nz
Contact person for public queries
Name 12814 0
Dr Mike Williams
Address 12814 0
Hinemoa House Medical Centre,
1271 Hinemoa Street,
Rotorua 3010
Country 12814 0
New Zealand
Phone 12814 0
+ 64 7 348 3002
Fax 12814 0
Email 12814 0
mwilliams@rgpg.co.nz
Contact person for scientific queries
Name 3742 0
Dr Mike Williams
Address 3742 0
Hinemoa House Medical Centre,
1271 Hinemoa Street,
Rotorua 3010
Country 3742 0
New Zealand
Phone 3742 0
+ 64 7 348 3002
Fax 3742 0
Email 3742 0
mwilliams@rgpg.co.nz

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.