InfluenzaNCT01431768
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
A study testing Respirio Flu Test in people with Influenza, run by Respirio Pty Ltd at 2 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 80 years
- Conditions the study is for
- Influenza
- What is being tested?
- Respirio Flu Test
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 2 sitesAustralia
- Study dates
- Jul 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects aged between 7 and 80 years (inclusive);
- Fever > 37.5 or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever;
- Cough or sore throat;
- Rhinorrhea or nasal congestion;
- ≤ 5 days from onset of clinical Influenza - Like Illness (ILI) symptoms;
- Subject (or parent/guardian) capable and willing to give informed consent;
- Subject provides written assent according to his/her age, if applicable.
Who cannot join
- Recent craniofacial abnormality or injury (last 3 months);
- Nasal or sinus surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
- Craniofacial abnormality, such as severe deviation of the nasal septum;
- Onset of clinical Influenza - Like Illness (ILI) symptoms > 5 days;
- Know history of allergic reaction to plastics or adhesives;
- Subject (or parent/guardian) unwilling or unable to give informed consent.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Taringa 7 Day Medical Practice
Brisbane, Queensland, 4068
Capalaba Medical Centre
Brisbane, Queensland, 4157
About this study
Official title: Clinical Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B in the Primary Health Setting
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.
- Conditions
- Influenza
- Being tested
- Respirio Flu Test
- Keywords
- Influenza, Human, Orthomyxoviridae infections, RNA Virus Infections, Virus Diseases, Respiratory Tract infections, Respiratory Tract Diseases
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respirio Flu TestDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of Influenza A
Measured: Day 1
Secondary outcomes (1)
Sensitivity and specificity of Influenza B
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Respirio Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie Todhunter, MBBS, Principal investigator, Unaffliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431768
- Sponsor's protocol ID
- RESP11001
- Status last verified
- Apr 2014
- First submitted
- 7 Sep 2011
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B in the Primary Health Setting
- ClinicalTrials.gov ID
- NCT01431768
- Acronym / sponsor ID
- RESP11001
- Conditions
- Influenza
- Keywords
- Influenza, Human, Orthomyxoviridae infections, RNA Virus Infections, Virus Diseases, Respiratory Tract infections, Respiratory Tract Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Respirio Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 7 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects aged between 7 and 80 years (inclusive);
- Fever > 37.5 or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever;
- Cough or sore throat;
- Rhinorrhea or nasal congestion;
- ≤ 5 days from onset of clinical Influenza - Like Illness (ILI) symptoms;
Key exclusion criteria (6 listed)
- Recent craniofacial abnormality or injury (last 3 months);
- Nasal or sinus surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
- Craniofacial abnormality, such as severe deviation of the nasal septum;
- Onset of clinical Influenza - Like Illness (ILI) symptoms > 5 days;
- Know history of allergic reaction to plastics or adhesives;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respirio Flu TestThe 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. | Device | – |
Primary outcome
Sensitivity and specificity of Influenza A
Time frame: Day 1
1 secondary outcome
Sensitivity and specificity of Influenza B
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Todhunter, MBBS principal investigator
Unaffliated
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respirio Flu Test in people with Influenza, run by Respirio Pty Ltd at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of Influenza A (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2014.