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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Respirio Pty Ltd
ClinicalTrials.gov Identifier:
NCT01431768
First received: September 7, 2011
Last updated: April 28, 2014
Last verified: April 2014
  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:


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
Study Completion Date: January 2012
Primary Completion Date: January 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431768

Locations
Australia, Queensland
Capalaba Medical Centre
Brisbane, Queensland, Australia, 4157
Taringa 7 Day Medical Practice
Brisbane, Queensland, Australia, 4068
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: April 28, 2014
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
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014