FLU A+B Nasal Swab Clinical Study - Full Text View

Sponsor:	Response Biomedical Corp.
Information provided by:	Response Biomedical Corp.
ClinicalTrials.gov Identifier:	NCT00636662

Purpose

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.

Condition	Intervention
Influenza	Other: Non-invasive diagnostic testing

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Evaluation of the RAMP FLU A+B Test Versus Viral Culture Using Clinical Nasal Swab Samples From Patients With Suspected Influenza Infections

Resource links provided by NLM:

MedlinePlus related topics: Flu

U.S. FDA Resources

Further study details as provided by Response Biomedical Corp.:

Primary Outcome Measures:

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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

mucous

Enrollment:	800
Study Start Date:	February 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
all any patient exhibiting symptoms of influenza	Other: Non-invasive diagnostic testing No patient treatment is altered by enrollment in this trial

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Nasal swab samples will be collected from subjects suspected of having influenza infections and onset has occurred within 3 days of examination. Across the sites these samples will be drawn from an approximately 60% pediatric patients (<21 years), and 40% adult patients (>21 years) and it is expected that the population will be divided approximately equally between males and females.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636662

Locations

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

Sponsors and Collaborators

Response Biomedical Corp.

More Information

No publications provided

Responsible Party:	Bryon Grove - Clinical Support Associate, Response Biomedical
ClinicalTrials.gov Identifier:	NCT00636662 History of Changes
Other Study ID Numbers:	CSP012
Study First Received:	March 7, 2008
Last Updated:	January 8, 2009
Health Authority:	United States: Institutional Review Board; Canada: Health Canada

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012