FLU A+B Nasal Swab Clinical Study

Completed

• Conditions: Influenza
• Interventions: Other: Non-invasive diagnostic testing

• Registration Number: NCT00636662
• Lead Sponsor: Response Biomedical Corp.

Brief Summary

The purpose of this clinical study is to obtain clearance for the nasal swab sample type by demonstrating the performance characteristics of the FLU A+B Test versus standard laboratory culture for Influenza A and B viruses using nasal swab samples.

Detailed Description

Patients exhibiting symptoms of influenza enrolled in a fashion that confidentiality of all personal health information is maintained.

No patient treatment is affected by enrollment in this trial.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-13
• Study First Posted: 2008-03-14
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Male and Female of all age groups
• Patients exhibiting influenza symptoms (i.e., fever, body aches, headaches, cough, sore throat, and other respiratory symptoms) at the time of examination
• Patients must either present with a fever (>100ºF; >37.8ºC) at time of examination or have had a fever (>100ºF; >37.8ºC) or declare at time of the examination that they had a fever within the previous 3 days prior to the examination
• Must be able to collect sample using the nasal swab sample type

Exclusion Criteria

• Patients with no fever at time of examination or within the 3 days prior to examination and/or are currently undergoing treatment (including anti-virals) will be excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
all	Non-invasive diagnostic testing	any patient exhibiting symptoms of influenza

Primary Outcome Measures

Name	Time	Method
Support the addition of nasal swab sample type to labeling for the FLU A+B Test. The nasal swab sample data will be analyzed for the FLU A+B Test versus standard laboratory culture identification to determine the sensitivity and specificity.	1 day

Trial Locations

Locations (5)

Washington University / St. Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Dell Children's Hospital; 🇺🇸 Austin, Texas, United States

Mt. Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada