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
1-3 The Terrace, Wellington 6011
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
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
Trial website
None
Trial related presentations / publications
None available
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 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 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.