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NCT00636662 Clinical Trial

FLU A+B Nasal Swab Clinical Study

Influenza Clinical Trial

— FLUA+B  

Official title:
Evaluation of the RAMP FLU A+B Test Versus Viral Culture Using Clinical Nasal Swab Samples From Patients With Suspected Influenza Infections

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00636662
Other study ID # CSP012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2008
Est. completion date May 2008

Study information
Verified date March 2019
Source Response Biomedical Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Non-invasive diagnostic testing
No patient treatment is altered by enrollment in this trial

Locations
Country Name City State
Canada Mt. Sinai Hospital Toronto Ontario
United States Dell Children's Hospital Austin Texas
United States Northwestern University Chicago Illinois
United States Washington University / St. Louis Children's Hospital Saint Louis Missouri
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Response Biomedical Corp.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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