Status:
COMPLETED
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
Lead Sponsor:
Respirio Pty Ltd
Conditions:
Influenza
Eligibility:
All Genders
7-80 years
Phase:
NA
Brief Summary
This is a open label, prospective, pair comparison, randomised, multi-centre trial. The primary aim of this study to is to clinically validate the sensitivity and specificity of the Respirio Flu Test ...
Eligibility Criteria
Inclusion
- Male and female subjects aged between 7 and 80 years (inclusive);
- Fever \> 37.5 or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever;
- Cough or sore throat;
- Rhinorrhea or nasal congestion;
- ≤ 5 days from onset of clinical Influenza - Like Illness (ILI) symptoms;
- Subject (or parent/guardian) capable and willing to give informed consent;
- Subject provides written assent according to his/her age, if applicable.
Exclusion
- Recent craniofacial abnormality or injury (last 3 months);
- Nasal or sinus surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
- Craniofacial abnormality, such as severe deviation of the nasal septum;
- Onset of clinical Influenza - Like Illness (ILI) symptoms \> 5 days;
- Know history of allergic reaction to plastics or adhesives;
- Subject (or parent/guardian) unwilling or unable to give informed consent.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01431768
Start Date
July 1 2011
End Date
January 1 2012
Last Update
April 30 2014
Active Locations (2)
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1
Taringa 7 Day Medical Practice
Brisbane, Queensland, Australia, 4068
2
Capalaba Medical Centre
Brisbane, Queensland, Australia, 4157