InfluenzaNCT03248960
Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
A study testing iTreat Flu A+B Test, ellume.lab Flu A+B Test and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in people with Influenza, run by Ellume Pty Ltd at 8 sites in Australia.
Trial summary
The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Influenza
- What is being tested?
- iTreat Flu A+B Test, ellume.lab Flu A+B Test and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 8 sitesAustralia
- Study dates
- 27 Jul 2017to 23 Dec 2017
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female participants aged ≥ 18 years: iTreat Flu A+B Test and ellume.lab Flu A+B Test OR aged ≥ 1 and <18 years: ellume.lab Flu A+B Test only; and
- Fever ≥ 37.8°C (100°F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8°C (100°F) or feeling feverish within 24 hours of presentation; and
- Rhonorrhea or blocked nose; and
- Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and
- Participant (or parent/legal guardian) able to read and write in English.
Who cannot join
- Participants aged <1 year.
- Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza (zanamivir) or Symmetral (amantadine) within the previous 7 days.
- Participants who have been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
- Participants who have had a nose bleed within the past 30 days.
- Participants who have had recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months.
- Participants currently enrolled in another clinical trial or have used any investigational device within 30 days preceding informed consent.
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- Participants 18 years of age or older unable to understand English and consent to participation.
- Parent/legal guardian of Paticipants <18 years of age unable to understand English and consent to participation of child.
- Participants who have had prior exposure to iTreat Flu A+B Test.
- participants who have been previously enrolled in the iE-FLU-AUS-1701 study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Australia8 sites
Paratus Clinical Blacktown Trial Clinic
Blacktown, New South Wales, 2148
Coastal Family Health
Buddina, Queensland, 4575
Ochre Health Medical Centre Casey
Casey, Australian Capital Territory, 2913
Paratus Clinical Kanwal Trial Clinic
Kanwal, New South Wales, 2559
Emeritus Research
Malvern East, Victoria, 3145
Morayfield Family Doctors
Morayfield, Queensland, 4506
USC Health Clinics
Sippy Downs, Queensland, 4556
Griffith University Clinical Trial Unit
Southport, Queensland, 4125
About this study
Official title: A Prospective Multi-Centre Study of the Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.
The secondary aims are to:
Read more
Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms.
Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test.
Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.
- Conditions
- Influenza
- Being tested
- iTreat Flu A+B Test, ellume.lab Flu A+B Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Viral culture
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTreat Flu A+B TestDiagnostic test
The iTreat Flu A+B Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples. The iTreat Flu A+B Test is designed to be simple to use and generates a result within 15 minutes.
ellume.lab Flu A+B TestDiagnostic test
The ellume.lab Flu A+B Test is an in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasal swab samples. The ellume.lab Flu A+B Test generates a result within 10 minutes.
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)Diagnostic test
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.
Viral cultureDiagnostic test
Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.
| Study group | Role | What they receive |
|---|---|---|
| iTreat Flu A+B Test and ellume.lab Flu A+B Test | Experimental | Upper respiratory tract samples from participants will be tested with:
iTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture. Receives: Diagnostic Test: iTreat Flu A+B Test; Diagnostic Test: ellume.lab Flu A+B Test; Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Diagnostic Test: Viral culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Secondary outcomes (11)
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by iTreat Flu A+B Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants positive for influenza A by RT-PCR, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Percent of participants who correctly interpret result of iTreat Flu A+B Test.
Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits
Measured: 1 day
Scores from questionnaire to assess ease of use, comfort and convenience of iTreat Flu A+B Test.
The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).
Measured: 1 day
Scores from questionnaire to assess ease of use and convenience of ellume.lab Flu A+B Test.
The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start27 Jul 2017
- Primary completion23 Dec 2017
- Study completion23 Dec 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellume Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248960
- Sponsor's protocol ID
- iE-FLU-AUS-1701
- Status last verified
- Jan 2018
- First submitted
- 10 Aug 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-Centre Study of the Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
- ClinicalTrials.gov ID
- NCT03248960
- Acronym / sponsor ID
- iE-FLU-AUS-1701
- Conditions
- Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Ellume Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 23 Dec 2017 (actual)
- Study completion
- 23 Dec 2017 (actual)
- First posted
- 15 Aug 2017 (actual)
- 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.
The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.
The secondary aims are to:
Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms.
Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test.
Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iTreat Flu A+B Test and ellume.lab Flu A+B Test | Experimental | Diagnostic Test: iTreat Flu A+B Test, Diagnostic Test: ellume.lab Flu A+B Test, Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Diagnostic Test: Viral cultureUpper respiratory tract samples from participants will be tested with: iTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female participants aged ≥ 18 years: iTreat Flu A+B Test and ellume.lab Flu A+B Test OR aged ≥ 1 and <18 years: ellume.lab Flu A+B Test only; and
- Fever ≥ 37.8°C (100°F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8°C (100°F) or feeling feverish within 24 hours of presentation; and
- Rhonorrhea or blocked nose; and
- Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and
- Participant (or parent/legal guardian) able to read and write in English.
Key exclusion criteria (10 listed)
- Participants aged <1 year.
- Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza (zanamivir) or Symmetral (amantadine) within the previous 7 days.
- Participants who have been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
- Participants who have had a nose bleed within the past 30 days.
- Participants who have had recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months.
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 |
|---|---|---|
| iTreat Flu A+B TestThe iTreat Flu A+B Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples. The iTreat Flu A+B Test is designed to be simple to use and generates a result within 15 minutes. | Diagnostic test | iTreat Flu A+B Test and ellume.lab Flu A+B Test |
| ellume.lab Flu A+B TestThe ellume.lab Flu A+B Test is an in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasal swab samples. The ellume.lab Flu A+B Test generates a result within 10 minutes. | Diagnostic test | iTreat Flu A+B Test and ellume.lab Flu A+B Test |
| 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. | Diagnostic test | iTreat Flu A+B Test and ellume.lab Flu A+B Test |
| Viral cultureNasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B. | Diagnostic test | iTreat Flu A+B Test and ellume.lab Flu A+B Test |
Primary outcome
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.
Time frame: 1 day
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
Time frame: 1 day
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test.
Time frame: 1 day
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.
Time frame: 1 day
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test.
Time frame: 1 day
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.
Time frame: 1 day
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test.
Time frame: 1 day
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.
Time frame: 1 day
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
11 secondary outcomes
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by iTreat Flu A+B Test.
Time frame: 1 day
Of participants positive for influenza A by RT-PCR, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
Time frame: 1 day
Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.
Time frame: 1 day
Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.
Time frame: 1 day
Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.
Time frame: 1 day
Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.
Time frame: 1 day
Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test.
Time frame: 1 day
Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.
Time frame: 1 day
Percent of participants who correctly interpret result of iTreat Flu A+B Test.
Time frame: 1 day
Scores from questionnaire to assess ease of use, comfort and convenience of iTreat Flu A+B Test.
Time frame: 1 day
Scores from questionnaire to assess ease of use and convenience of ellume.lab Flu A+B Test.
Time frame: 1 day
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 1 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTreat Flu A+B Test, ellume.lab Flu A+B Test and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in people with Influenza, run by Ellume Pty Ltd at 8 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 5 inclusion and 10 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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test. (time frame: 1 day). The study lists 8 primary outcomes in all. 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 1 Feb 2018.