Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03248960




Registration number
NCT03248960
Ethics application status
Date submitted
10/08/2017
Date registered
15/08/2017
Date last updated
1/02/2018

Titles & IDs
Public title
Ellume.Lab Flu A+B Test and iTreat Flu A+B 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 iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
Secondary ID [1] 0 0
iE-FLU-AUS-1701
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 - iTreat Flu A+B Test
Diagnosis / Prognosis - ellume.lab Flu A+B Test
Diagnosis / Prognosis - Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Diagnosis / Prognosis - Viral culture

Experimental: iTreat Flu A+B Test and ellume.lab Flu A+B Test - 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.


Diagnosis / Prognosis: iTreat Flu A+B 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.

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

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 viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.
Timepoint [1] 0 0
1 day
Primary 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.
Timepoint [2] 0 0
1 day
Primary outcome [3] 0 0
Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test.
Timepoint [3] 0 0
1 day
Primary 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.
Timepoint [4] 0 0
1 day
Primary outcome [5] 0 0
Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test.
Timepoint [5] 0 0
1 day
Primary 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.
Timepoint [6] 0 0
1 day
Primary outcome [7] 0 0
Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test.
Timepoint [7] 0 0
1 day
Primary 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.
Timepoint [8] 0 0
1 day
Secondary 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 iTreat Flu A+B Test.
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
Of participants positive for influenza A by RT-PCR, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
Timepoint [2] 0 0
1 day
Secondary outcome [3] 0 0
Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.
Timepoint [3] 0 0
1 day
Secondary outcome [4] 0 0
Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.
Timepoint [4] 0 0
1 day
Secondary outcome [5] 0 0
Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.
Timepoint [5] 0 0
1 day
Secondary outcome [6] 0 0
Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.
Timepoint [6] 0 0
1 day
Secondary outcome [7] 0 0
Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test.
Timepoint [7] 0 0
1 day
Secondary outcome [8] 0 0
Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.
Timepoint [8] 0 0
1 day
Secondary outcome [9] 0 0
Percent of participants who correctly interpret result of iTreat Flu A+B Test.
Timepoint [9] 0 0
1 day
Secondary outcome [10] 0 0
Scores from questionnaire to assess ease of use, comfort and convenience of iTreat Flu A+B Test.
Timepoint [10] 0 0
1 day
Secondary outcome [11] 0 0
Scores from questionnaire to assess ease of use and convenience of ellume.lab Flu A+B Test.
Timepoint [11] 0 0
1 day

Eligibility
Key inclusion criteria
- 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.
Minimum age
1 Year
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

- 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.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/12/2017
Sample size
Target
Accrual to date
Final
381
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Ochre Health Medical Centre Casey - Casey
Recruitment hospital [2] 0 0
Paratus Clinical Blacktown Trial Clinic - Blacktown
Recruitment hospital [3] 0 0
Paratus Clinical Kanwal Trial Clinic - Kanwal
Recruitment hospital [4] 0 0
Coastal Family Health - Buddina
Recruitment hospital [5] 0 0
Morayfield Family Doctors - Morayfield
Recruitment hospital [6] 0 0
USC Health Clinics - Sippy Downs
Recruitment hospital [7] 0 0
Griffith University Clinical Trial Unit - Southport
Recruitment hospital [8] 0 0
Emeritus Research - Malvern East
Recruitment postcode(s) [1] 0 0
2913 - Casey
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2559 - Kanwal
Recruitment postcode(s) [4] 0 0
4575 - Buddina
Recruitment postcode(s) [5] 0 0
4506 - Morayfield
Recruitment postcode(s) [6] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [7] 0 0
4125 - Southport
Recruitment postcode(s) [8] 0 0
3145 - Malvern East

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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03248960
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03248960