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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
Not applicable
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
Not applicable
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
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).

The secondary aims are to:

* validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza B , when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
* assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza A;
* assess agreement (positive and negative) between Respirio Flu Test and Sofia® Influenza A+B Test in detecting Influenza B;
* evaluate the correct interpretation of the Respirio Flu Test results by subjects with Influenza-like illness symptoms;
* evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test;
* evaluate the subjects' comprehension of the Respirio Flu Test labelling; and
* establish the minimum sample weight required to achieve a result with the Respirio Flu Test.
Trial website
https://clinicaltrials.gov/study/NCT02487173
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02487173