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

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Respirio Flu Test
Sponsored by
Respirio Pty Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Influenza focused on measuring Influenza, Human, Orthomyxoviridae infections, RNA Virus Infections, Virus Diseases, Respiratory Tract infections, Respiratory Tract Diseases

Eligibility Criteria

7 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taringa 7 Day Medical Practice
  • Capalaba Medical Centre

Outcomes

Primary Outcome Measures

Sensitivity and specificity of Influenza A

Secondary Outcome Measures

Sensitivity and specificity of Influenza B

Full Information

First Posted
September 7, 2011
Last Updated
April 28, 2014
Sponsor
Respirio Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01431768
Brief Title
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
Official Title
Clinical Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B in the Primary Health Setting
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Respirio Pty Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Human, Orthomyxoviridae infections, RNA Virus Infections, Virus Diseases, Respiratory Tract infections, Respiratory Tract Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Respirio Flu Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of Influenza A
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of Influenza B
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Todhunter, MBBS
Organizational Affiliation
Unaffliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taringa 7 Day Medical Practice
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4068
Country
Australia
Facility Name
Capalaba Medical Centre
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4157
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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