InfluenzaNCT03595358

Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction

A study testing Ellume Home Flu 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 1 site 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 the study is to validate the sensitivity and specificity of the Ellume Home Flu 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) Secondary aims are to: Validate the sensitivity and specificity of… Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Influenza
What is being tested?: Ellume Home Flu 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: 25 participants
Where: 1 siteAustralia
Study dates: 31 Aug 2018to 16 Nov 2018
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 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male and female participants aged ≥ 2 years; and
Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation; and
Rhinorrhea; and
≤ 72 hours from onset of ILI symptoms; 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 < 2 years.
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 used any investigational device within 30 days preceding informed consent.

Show all 9Show fewer

Participants previously enrolled in IE-FLU-AUS-1801;
Participants 18 years of age or older unable to understand English and consent to participation;
Parent/legal guardian of participants < 18 years of age unable to understand English and consent to participation of child.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Paratus Clinical Kanwal Trial Clinic
Kanwal, New South Wales, 2559

Other trials in Australia

About this study

Official title: A Prospective Multi-Centre Study of the Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction

Secondary aims are to:

Validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture; Evaluate the participant's satisfaction with the convenience and ease of use of the Ellume Home Flu Test; Evaluate the participant's interpretation of the Ellume Home Flu Test results compared to the interpretation by site staff; Evaluate the operator's satisfaction and ease of use of the ellume·lab Flu A+B Test.

Conditions: Influenza
Being tested: Ellume Home Flu 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.

Ellume Home Flu TestDiagnostic test
The Ellume Home Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples.
ellume.lab Flu A+B TestDiagnostic test
The ellume.lab Flu A+B Test is a rapid 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.
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 groups in NCT03595358
Study group	Role	What they receive
Arm	Experimental	Ellume Home Flu Test and ellume.lab Flu A+B Test Upper respiratory tract samples from participants will be tested with: Ellume Home Flu Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and viral culture. Receives: Diagnostic Test: Ellume Home Flu 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 Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Ellume Home Flu Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Measured: 1 day
Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.
Measured: 1 day
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Ellume Home Flu Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Measured: 1 day
Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.
Measured: 1 day
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Ellume Home Flu Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Measured: 1 day
Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.
Measured: 1 day
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Ellume Home Flu Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
Measured: 1 day
Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.
Measured: 1 day

Secondary outcomes (11)

Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test.
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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 intervals.
Measured: 1day
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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 intervals.
Measured: 1 day
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu 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 intervals.
Measured: 1 day
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test.
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
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 intervals.
Measured: 1 day
Percent of participants who correctly interpret the result of the Ellume Home Flu Test
Agreement between trained staff and participants. Report as a percentage of participants with 96% confidence limits.
Measured: 1 day
Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home 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: 1 day
Scores from questionnaire to assess ease of use and convenience of the 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.

31 Aug 201816 Nov 2018

First posted23 Jul 2018
Study start31 Aug 2018
Primary completion16 Nov 2018
Study completion16 Nov 2018

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: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03595358
Sponsor's protocol ID: IE-FLU-AUS-1801
Status last verified: Jun 2023
First submitted: 11 Jul 2018
Last updated: 15 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. 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 the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction
ClinicalTrials.gov ID: NCT03595358
Acronym / sponsor ID: IE-FLU-AUS-1801
Conditions: Influenza
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Ellume Pty LtdIndustry (pharma, biotech, devices)
Study start: 31 Aug 2018 (actual)
Primary completion: 16 Nov 2018 (actual)
Study completion: 16 Nov 2018 (actual)
First posted: 23 Jul 2018 (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.

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
Arm	Experimental	Diagnostic Test: Ellume Home Flu Test, Diagnostic Test: ellume.lab Flu A+B Test, Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Diagnostic Test: Viral cultureEllume Home Flu Test and ellume.lab Flu A+B Test Upper respiratory tract samples from participants will be tested with: Ellume Home Flu Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and viral culture.

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Male and female participants aged ≥ 2 years; and
Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation; and
Rhinorrhea; and
≤ 72 hours from onset of ILI symptoms; and
Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and

Key exclusion criteria (9 listed)

Participants aged < 2 years.
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
Ellume Home Flu TestThe Ellume Home Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples.	Diagnostic test	Arm
ellume.lab Flu A+B TestThe ellume.lab Flu A+B Test is a rapid 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.	Diagnostic test	Arm
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	Arm
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	Arm

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

11 secondary outcomes

Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test.
Time frame: 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.
Time frame: 1day
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test.
Time frame: 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.
Time frame: 1 day
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu Test.
Time frame: 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.
Time frame: 1 day
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test.
Time frame: 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.
Time frame: 1 day
Percent of participants who correctly interpret the result of the Ellume Home Flu Test
Time frame: 1 day
Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home Flu Test.
Time frame: 1 day
Scores from questionnaire to assess ease of use and convenience of the 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 15 Jun 2023.

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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Ellume Home Flu 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 1 site 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 6 inclusion and 9 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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Ellume Home Flu 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?

On the ClinicalTrials.gov record for NCT03595358.

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 15 Jun 2023.