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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02487173




Registration number
NCT02487173
Ethics application status
Date submitted
26/06/2015
Date registered
1/07/2015
Date last updated
15/07/2016

Titles & IDs
Public title
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
Scientific title
A Prospective Multi-Centre Study of the Respirio Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and Sofia® Influenza A+B Fluorescent Immunoassay (FIA) for the Rapid Detection of Influenza A/B
Secondary ID [1] 0 0
RESP15001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 0 0
Influenza B 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Respirio Flu Test
Treatment: Devices - Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Treatment: Devices - Sofia® Influenza A+B Fluorescent Immunoassay (FIA)

Experimental: Respirio Flu Test - Upper respiratory tract samples from participants will be tested with:

* Respirio Flu Test
* Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
* Sofia® Influenza A+B Fluorescent Immunoassay (FIA)


Treatment: Devices: Respirio Flu Test
The Respirio Flu Test is a rapid test for the detection of influenza A or influenza B in nasal secretions. The Respirio Flu Test is designed to be simple to use and generates a result within 20 minutes.

Treatment: Devices: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse-transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.

Treatment: Devices: Sofia® Influenza A+B Fluorescent Immunoassay (FIA)
Sofia® Influenza A+B Fluorescent Immunoassay (FIA) employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash samples taken directly from symptomatic patients.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Of participants positive for influenza A by ReverseTranscriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Respirio Flu Test.
Timepoint [1] 0 0
Day 1
Primary outcome [2] 0 0
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Respirio Flu Test.
Timepoint [2] 0 0
Day 1
Secondary outcome [1] 0 0
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Respirio Flu Test.
Timepoint [1] 0 0
Day 1
Secondary outcome [2] 0 0
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Respirio Flu Test.
Timepoint [2] 0 0
Day 1
Secondary outcome [3] 0 0
Percent of participants positive for influenza A by Sofia® Influenza A+B Test and Respirio Flu Test.
Timepoint [3] 0 0
Day 1
Secondary outcome [4] 0 0
Percent of participants negative for influenza B by Sofia® Influenza A+B Test and Respirio Flu Test.
Timepoint [4] 0 0
Day 1
Secondary outcome [5] 0 0
Combine positive and negative agreement of Respirio Flu Test and Sofia® Influenza A+B Test to establish overall agreement. Report as a percentage of participants with 95% confidence limits.
Timepoint [5] 0 0
Day 1
Secondary outcome [6] 0 0
Percent of participants who correctly interpret result of Respirio Flu Test.
Timepoint [6] 0 0
Day 1
Secondary outcome [7] 0 0
Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test.
Timepoint [7] 0 0
Day 1
Secondary outcome [8] 0 0
Percent of participants correctly determining eligibility and conditions for use of Respirio Flu Test from scores on a label comprehension questionnaire.
Timepoint [8] 0 0
Day 1
Secondary outcome [9] 0 0
Weight of sample deposited in Respirio Flu Test.
Timepoint [9] 0 0
Day 1

Eligibility
Key inclusion criteria
* Male and female subjects aged = 1 year;
* Rhinorrhea;
* = 72 hours from onset of Influenza-like illness symptoms;
* Subject (or parent/legal guardian) capable and willing to give informed consent/assent.
* Subject (or parent/legal guardian) able to read and write in English.
Minimum age
1 Year
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has undergone treatment with antivirals within the previous 7 days;
* Has been vaccinated by means of an Influenza nasal spray/mist vaccine within the previous 7 days;
* Recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
* Currently enrolled in another clinical trial or used any investigational device within 90 days preceding informed consent;
* Has had prior exposure to the Respirio Flu Test;
* Subject (or parent/legal guardian) residing at the same residential address as a subject currently enrolled in this study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
NA
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Taringa 7 Day Medical Practice - Brisbane
Recruitment hospital [2] 0 0
Graceville Medical - Brisbane
Recruitment hospital [3] 0 0
Inala Primary Care - Brisbane
Recruitment hospital [4] 0 0
Limestone Medical Centre - Ipswich
Recruitment postcode(s) [1] 0 0
4068 - Brisbane
Recruitment postcode(s) [2] 0 0
4075 - Brisbane
Recruitment postcode(s) [3] 0 0
4077 - Brisbane
Recruitment postcode(s) [4] 0 0
4305 - Ipswich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ellume Pty Ltd
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02487173