Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01431768
NCT01431768CompletedNot Applicable

Clinical Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B in the Primary Health Setting

Respirio Pty Ltd4 sites in 1 country250 target enrollmentStarted: July 1, 2011Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
250
Locations
4
Primary Endpoint
Sensitivity and specificity of Influenza A
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
7 Years to 80 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Sensitivity and specificity of Influenza A

Time Frame: Day 1

Secondary Outcomes

  • Sensitivity and specificity of Influenza B(Day 1)

Investigators

Sponsor
Respirio Pty Ltd
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

Loading locations...

Similar Trials

Completed
Not Applicable
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/BInfluenza BInfluenza A
NCT02487173Ellume Pty Ltd83
Completed
Phase 3
Efficacy Safety Study of Flu Vaccine in Immunodepression PatientsInflammatory Bowel Disease (IBD)
NCT01022749Assistance Publique - Hôpitaux de Paris228
Completed
Not Applicable
Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/BInfluenza BInfluenza A
NCT02767414Ellume Pty Ltd1,500
Completed
Phase 3
Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza VaccinationInfection in Solid Organ Transplant Recipients
NCT01761435Fundación Pública Andaluza Progreso y Salud499
Completed
Not Applicable
Evaluation of the Roche Liat Flu/RSV Assay for Management of Influenza in the Emergency DepartmentInfluenza, Human
NCT02899065University of California, Davis200