FLU A+B Nasal Swab Clinical Study (FLUA+B)
This study has been completed.
Sponsor:
Response Biomedical Corp.
Information provided by:
Response Biomedical Corp.
ClinicalTrials.gov Identifier:
NCT00636662
First received: March 7, 2008
Last updated: January 8, 2009
Last verified: January 2009
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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:
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 May 19, 2013