Clinical trial NCT02767414: Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza A
Influenza B
Lead sponsor: Ellume Pty Ltd
Sponsor class: INDUSTRY
First posted: 2016-05-10
Enrollment: 1500
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
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.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
Secondary outcomes:
measure: 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.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
measure: Percent of participants who correctly interpret result of Respirio Flu Test.
timeFrame: Day 1
measure: Scores from questionnaire to assess ease of use, comfort and convenience of Respirio Flu Test.
timeFrame: Day 1
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Red Hill Doctors Surgery
state: Queensland
city: Brisbane
country: Australia
facility: Mater Hospital - Brisbane
state: Queensland
city: Brisbane
country: Australia
facility: Doctors@Carindale
state: Queensland
city: Redland
country: Australia
facility: Capalaba Medical Centre
state: Queensland
city: Sippy Downs
country: Australia
facility: Clinical Trials Centre - University of the Sunshine Coast
state: Queensland
city: Geelong
country: Australia
facility: Barwon Health - Geelong
state: Victoria
city: Melbourne
country: Australia
facility: The Royal Children's Hospital
state: Victoria
Study officials:
affiliation: Australian Paediatric Pharmacology Research Unit, Royal Children's Hospital
name: Noel Cranswick
role: PRINCIPAL_INVESTIGATOR
affiliation: Barwon Health - Geelong
name: James Pollard
role: PRINCIPAL_INVESTIGATOR
affiliation: Mater Hospital - Brisbane
name: Paul Griffin
role: PRINCIPAL_INVESTIGATOR
affiliation: Doctors@Carindale
name: Stephen Windley
role: PRINCIPAL_INVESTIGATOR
affiliation: Capalaba Medical Centre
name: Luke Katahanas
role: PRINCIPAL_INVESTIGATOR
affiliation: Red Hill Doctors Surgery
name: Bernardine McKellar
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sunshine Coast Clinical Trials Centre
name: Evan Jones
role: PRINCIPAL_INVESTIGATOR
References: