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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03595358




Registration number
NCT03595358
Ethics application status
Date submitted
11/07/2018
Date registered
23/07/2018
Date last updated
24/09/2018

Titles & IDs
Public title
Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction
Scientific 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 ID [1] 0 0
IE-FLU-AUS-1801
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
Diagnosis / Prognosis - Ellume Home Flu Test
Diagnosis / Prognosis - ellume.lab Flu A+B Test
Diagnosis / Prognosis - Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Diagnosis / Prognosis - Viral culture

Experimental: Arm - 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.


Diagnosis / Prognosis: Ellume Home Flu 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.

Diagnosis / Prognosis: ellume.lab Flu A+B 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.

Diagnosis / Prognosis: 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.

Diagnosis / Prognosis: Viral culture
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.

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 day
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
1 day
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
1 day
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
1 day
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
1 day
Primary outcome [6] 0 0
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.
Timepoint [6] 0 0
1 day
Primary outcome [7] 0 0
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.
Timepoint [7] 0 0
1 day
Primary outcome [8] 0 0
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.
Timepoint [8] 0 0
1 day
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
1day
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
1 day
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
1 day
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
1 day
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
1 day
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
1 day
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
1 day
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
1 day
Secondary outcome [10] 0 0
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).
Timepoint [10] 0 0
1 day
Secondary outcome [11] 0 0
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).
Timepoint [11] 0 0
1 day

Eligibility
Key inclusion criteria
- 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.
Minimum age
2 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

- 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Paratus Clinical Kanwal Trial Clinic - Kanwal
Recruitment postcode(s) [1] 0 0
2559 - Kanwal

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

Ethics approval
Ethics application status

Summary
Brief 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 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.
Trial website
https://clinicaltrials.gov/show/NCT03595358
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Debbie Brezac
Address 0 0
Country 0 0
Phone 0 0
+61 7 33931448
Fax 0 0
Email 0 0
debbie.brezac@ellume.com.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03595358