Status:
COMPLETED
Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
Lead Sponsor:
Ellume Pty Ltd
Conditions:
Influenza
Eligibility:
All Genders
1+ years
Phase:
NA
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 vira...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2017
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT03248960
Start Date
July 27 2017
End Date
December 23 2017
Last Update
February 1 2018
Active Locations (8)
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1
Ochre Health Medical Centre Casey
Casey, Australian Capital Territory, Australia, 2913
2
Paratus Clinical Blacktown Trial Clinic
Blacktown, New South Wales, Australia, 2148
3
Paratus Clinical Kanwal Trial Clinic
Kanwal, New South Wales, Australia, 2559
4
Coastal Family Health
Buddina, Queensland, Australia, 4575