Status:

COMPLETED

FLU A+B Nasal Swab Clinical Study

Lead Sponsor:

Response Biomedical Corp.

Conditions:

Influenza

Eligibility:

All Genders

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 Inf...

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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 1 2008

Estimated Enrollment :

800 Patients enrolled

Trial Details

Trial ID

NCT00636662

Start Date

February 1 2008

End Date

May 1 2008

Last Update

March 27 2019

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Northwestern University

Chicago, Illinois, United States

2

Washington University / St. Louis Children's Hospital

St Louis, Missouri, United States

3

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

4

Dell Children's Hospital

Austin, Texas, United States