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Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B

This study is currently recruiting participants.
Verified September 2011 by Respirio Pty Ltd
Sponsor:
Information provided by (Responsible Party):
Respirio Pty Ltd
ClinicalTrials.gov Identifier:
NCT01431768
First received: September 7, 2011
Last updated: September 10, 2011
Last verified: September 2011
History of Changes
  Purpose

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 (RFT) in detecting Influenza A as compared with (a) the best available rapid Influenza A test in the market Quidel QuickVue (QQV) and (b) the gold standard for identifying Influenza A infection Polymerase Chain Reaction (PCR).

The secondary aim is to clinically validate the sensitivity and specificity of the Respirio Flu Test (RFT) in detecting Influenza B as compared to QQV and PCR.


Condition Intervention
Influenza
 Device: Respirio Flu Test

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B in the Primary Health Setting

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Respirio Pty Ltd:

Primary Outcome Measures:
  • Sensitivity and specificity of Influenza A [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity and specificity of Influenza B [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: July 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Respirio Flu Test
    The Respirio Flu Test (RFT) is a rapid test for identifying whether a patient is infected with the Influenza A or B virus. The test separates the Influenza virus from the patient's nose blow sample and utilizes the same underlying technology as a pregnancy test (lateral flow/immuno-chromatography) to deliver a positive or negative result in less than 10 minutes. The RFT is easy to use, designed with a 3 step process similar to that of the home pregnancy test. Results are presented to the patient as a combination of different coloured lines, depending on whether the patient has Influenza A or B.
  Eligibility

Ages Eligible for Study:   7 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects aged between 7 and 80 years (inclusive);
  2. Fever > 37.5 or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever;
  3. Cough or sore throat;
  4. Rhinorrhea or nasal congestion;
  5. ≤ 5 days from onset of clinical Influenza - Like Illness (ILI) symptoms;
  6. Subject (or parent/guardian) capable and willing to give informed consent;
  7. Subject provides written assent according to his/her age, if applicable.

Exclusion Criteria:

  1. Recent craniofacial abnormality or injury (last 3 months);
  2. Nasal or sinus surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
  3. Craniofacial abnormality, such as severe deviation of the nasal septum;
  4. Onset of clinical Influenza - Like Illness (ILI) symptoms > 5 days;
  5. Know history of allergic reaction to plastics or adhesives;
  6. Subject (or parent/guardian) unwilling or unable to give informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431768

Contacts
Contact: Julie Todhunter, MBBS 07 3870 7666 zags@bigpond.net.au

Locations
Australia, Queensland
Taringa 7 Day Medical Practice Recruiting
Brisbane, Queensland, Australia, 4068
Contact: Robert D Gooch, MBBS     61 7 3870 7239     robert.gooch@ipnet.com.au    
Principal Investigator: Robert D Gooch, MBBS            
Capalaba Medical Centre Recruiting
Brisbane, Queensland, Australia, 4157
Contact: Lucas G Katahanas, MBBS     61 7 3245 9600     capmed@onthenet.com.au    
Principal Investigator: Lucas G Katahanas, MBBS            
Sponsors and Collaborators
Respirio Pty Ltd
Investigators
Principal Investigator: Julie Todhunter, MBBS Unaffliated
  More Information

No publications provided

Responsible Party: Respirio Pty Ltd
ClinicalTrials.gov Identifier: NCT01431768     History of Changes
Other Study ID Numbers: RESP11001
Study First Received: September 7, 2011
Last Updated: September 10, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Respirio Pty Ltd:
Influenza
Human
Orthomyxoviridae infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract infections
Respiratory Tract Diseases

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013