Influenza ANCT02767414

Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B

A study testing Respirio Flu Test, eLab Flu Test and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) in people with Influenza A and Influenza B, run by Ellume Pty Ltd at 7 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). Read more about this study

Who is it for?: Ages 1 year and older
Conditions the study is for: Influenza A, Influenza B
What is being tested?: Respirio Flu Test, eLab Flu Test and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,500 participants
Where: 7 sitesAustralia
Study dates: Jul 2016to Oct 2016
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 subjects aged ≥ 1 year;
Rhinorrhea;
≤ 5 days 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 English.

Who cannot join

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 or eLab Flu Test.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Australia7 sites

Red Hill Doctors Surgery
Brisbane, Queensland, 4059
Mater Hospital - Brisbane
Brisbane, Queensland, 4101
Doctors@Carindale
Brisbane, Queensland, 4152
Barwon Health - Geelong
Geelong, Victoria, 3220
The Royal Children's Hospital
Melbourne, Victoria, 3052
Capalaba Medical Centre
Redland, Queensland, 4157
Clinical Trials Centre - University of the Sunshine Coast
Sippy Downs, Queensland, 4556

Other trials in Australia

About this study

Official title: A Prospective Multi-centre Study of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) for the Rapid Detection of Influenza A/B

The secondary aims are to:

Validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza B as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Evaluate the correct interpretation of the Respirio Flu Test by subjects with influenza-like symptoms; Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test.

Conditions: Influenza A, Influenza B
Being tested: Respirio Flu Test, eLab Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

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 is a rapid in vitro diagnostic 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.
eLab Flu TestDevice
The eLab Flu 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 nasopharyngeal swab samples. The eLab Flu Test generates a result within 10 minutes.
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)Device
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.

Study groups in NCT02767414
Study group	Role	What they receive
Respirio Flu Test and eLab Flu Test	Experimental	Upper respiratory tract samples from participants will be tested with: Respirio Flu Test; eLab Flu Test; and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) Receives: Device: Respirio Flu Test; Device: eLab Flu Test; Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

What is being measured

The primary outcome is the main question the study is designed to answer.

Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Respirio Flu Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: Day 1
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by eLab Flu Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: Day 1
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.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: Day 1
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by eLab Flu Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: Day 1

Secondary outcomes (6)

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.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: Day 1
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by eLab Flu Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: Day 1
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.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: Day 1
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by eLab Flu Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Measured: Day 1
Percent of participants who correctly interpret result of Respirio Flu Test.
Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits.
Measured: Day 1
Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu 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: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016Oct 2016

First posted10 May 2016 (estimated)
Study startJul 2016
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Influenza AStudies 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: 1,500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02767414
Sponsor's protocol ID: RESP16001
Status last verified: Dec 2016
First submitted: 6 May 2016
Last updated: 6 Dec 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Healthy Participants

All Influenza A trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multi-centre Study of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test Performance Versus Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) for the Rapid Detection of Influenza A/B
ClinicalTrials.gov ID: NCT02767414
Acronym / sponsor ID: RESP16001
Conditions: Influenza A, Influenza B
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,500 participants (actual)
Lead sponsor: Ellume Pty LtdIndustry (pharma, biotech, devices)
Study start: Jul 2016
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 10 May 2016 (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.

The secondary aims are to:

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Respirio Flu Test and eLab Flu Test	Experimental	Device: Respirio Flu Test, Device: eLab Flu Test, Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)Upper respiratory tract samples from participants will be tested with: Respirio Flu Test; eLab Flu Test; and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

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 subjects aged ≥ 1 year;
Rhinorrhea;
≤ 5 days 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 English.

Key exclusion criteria (5 listed)

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 or eLab Flu Test.

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 is a rapid in vitro diagnostic 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.	Device	Respirio Flu Test and eLab Flu Test
eLab Flu TestThe eLab Flu 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 nasopharyngeal swab samples. The eLab Flu Test generates a result within 10 minutes.	Device	Respirio Flu Test and eLab Flu 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.	Device	Respirio Flu Test and eLab Flu Test

Primary outcome

Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Respirio Flu Test.
Time frame: Day 1
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by eLab Flu Test.
Time frame: Day 1
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.
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.
Time frame: Day 1
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by eLab Flu Test.
Time frame: Day 1
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.

6 secondary outcomes

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.
Time frame: Day 1
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by eLab Flu Test.
Time frame: Day 1
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.
Time frame: Day 1
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by eLab Flu Test.
Time frame: Day 1
Percent of participants who correctly interpret result of Respirio Flu Test.
Time frame: Day 1
Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test.
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 6 Dec 2016.
Individual participant dataSharing planned: No

Related trials for Influenza A

Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
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A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
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A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
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RecruitingPhase 1
A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone® HD Vaccine (CD388.SQ.1.08/MK-1406-007)
Healthy Participants

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.

Noel Cranswick principal investigator

Australian Paediatric Pharmacology Research Unit, Royal Children's Hospital

James Pollard principal investigator

Barwon Health - Geelong

Paul Griffin principal investigator

Mater Hospital - Brisbane

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Respirio Flu Test. (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02767414.

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 6 Dec 2016.