Clinical trial NCT03248960: Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Lead sponsor: Ellume Pty Ltd
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 381
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 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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.
timeFrame: 1 day
measure: Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test.
timeFrame: 1 day
measure: Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test.
timeFrame: 1 day
measure: Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test.
timeFrame: 1 day
measure: Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.
timeFrame: 1 day
Secondary 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 iTreat Flu A+B Test.
timeFrame: 1 day
measure: Of participants positive for influenza A by RT-PCR, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.
timeFrame: 1 day
measure: Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.
timeFrame: 1 day
measure: Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test.
timeFrame: 1 day
measure: Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Percent of participants who correctly interpret result of iTreat Flu A+B Test.
timeFrame: 1 day
measure: Scores from questionnaire to assess ease of use, comfort and convenience of iTreat Flu A+B Test.
timeFrame: 1 day
measure: Scores from questionnaire to assess ease of use and convenience of ellume.lab Flu A+B Test.
timeFrame: 1 day
Other outcomes:
Locations:
city: Casey
country: Australia
facility: Ochre Health Medical Centre Casey
state: Australian Capital Territory
city: Blacktown
country: Australia
facility: Paratus Clinical Blacktown Trial Clinic
state: New South Wales
city: Kanwal
country: Australia
facility: Paratus Clinical Kanwal Trial Clinic
state: New South Wales
city: Buddina
country: Australia
facility: Coastal Family Health
state: Queensland
city: Morayfield
country: Australia
facility: Morayfield Family Doctors
state: Queensland
city: Sippy Downs
country: Australia
facility: USC Health Clinics
state: Queensland
city: Southport
country: Australia
facility: Griffith University Clinical Trial Unit
state: Queensland
city: Malvern East
country: Australia
facility: Emeritus Research
state: Victoria
Study officials:
References: