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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01431768




Registration number
NCT01431768
Ethics application status
Date submitted
7/09/2011
Date registered
12/09/2011
Date last updated
30/04/2014

Titles & IDs
Public title
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
Scientific title
Clinical Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B in the Primary Health Setting
Secondary ID [1] 0 0
RESP11001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Respirio Flu Test

Treatment: Devices: Respirio Flu Test
The Respirio Flu Test (RFT) is a rapid test for identifying whether a patient is infected with the Influenza A or B virus. The test separates the Influenza virus from the patient's nose blow sample and utilizes the same underlying technology as a pregnancy test (lateral flow/immuno-chromatography) to deliver a positive or negative result in less than 10 minutes. The RFT is easy to use, designed with a 3 step process similar to that of the home pregnancy test. Results are presented to the patient as a combination of different coloured lines, depending on whether the patient has Influenza A or B.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity and specificity of Influenza A
Timepoint [1] 0 0
Day 1
Secondary outcome [1] 0 0
Sensitivity and specificity of Influenza B
Timepoint [1] 0 0
Day 1

Eligibility
Key inclusion criteria
1. Male and female subjects aged between 7 and 80 years (inclusive);

2. Fever > 37.5 or a self-reported history of fever or feeling feverish (includes fever
controlled by medication) in the absence of documented fever;

3. Cough or sore throat;

4. Rhinorrhea or nasal congestion;

5. = 5 days from onset of clinical Influenza - Like Illness (ILI) symptoms;

6. Subject (or parent/guardian) capable and willing to give informed consent;

7. Subject provides written assent according to his/her age, if applicable.
Minimum age
7 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Recent craniofacial abnormality or injury (last 3 months);

2. Nasal or sinus surgery, including surgery to correct deviation of the nasal septum,
within the previous 6 months;

3. Craniofacial abnormality, such as severe deviation of the nasal septum;

4. Onset of clinical Influenza - Like Illness (ILI) symptoms > 5 days;

5. Know history of allergic reaction to plastics or adhesives;

6. Subject (or parent/guardian) unwilling or unable to give informed consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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
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
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Taringa 7 Day Medical Practice - Brisbane
Recruitment hospital [2] 0 0
Capalaba Medical Centre - Brisbane
Recruitment postcode(s) [1] 0 0
4068 - Brisbane
Recruitment postcode(s) [2] 0 0
4157 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Respirio Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a open label, prospective, pair comparison, randomised, multi-centre trial. The
primary aim of this study to is to clinically validate the sensitivity and specificity of the
Respirio Flu Test (RFT) in detecting Influenza A as compared with (a) the best available
rapid Influenza A test in the market Quidel QuickVue (QQV) and (b) the gold standard for
identifying Influenza A infection Polymerase Chain Reaction (PCR).

The secondary aim is to clinically validate the sensitivity and specificity of the Respirio
Flu Test (RFT) in detecting Influenza B as compared to QQV and PCR.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01431768
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Julie Todhunter, MBBS
Address 0 0
Unaffliated
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/ct2/show/NCT01431768