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Sponsored by: |
Nanogen, Inc. |
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Information provided by: | Nanogen, Inc. |
ClinicalTrials.gov Identifier: | NCT00828100 |
The primary objective of this study is to compare the performance of the investigational fluid Rapid Influenza Test and the BinaxNOW® Influenza A & B Test in detecting influenza type A and influenza type B.
Condition | Intervention | Phase |
---|---|---|
Influenza |
Device: fluID Rapid Influenza Test Device: BinaxNOW® Influenza A & B |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Comparison of fluID Rapid Influenza and BinaxNOW® Influenza A & B |
Estimated Enrollment: | 650 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
The primary objective of this study is to compare the performance of the investigational fluID Rapid Influenza Test and the BinaxNOW® Influenza A & B Test in detecting influenza type A and influenza type B, with respect to fresh nasal wash / aspirate specimens collected from patients presenting with signs and symptoms of influenza-like illness (ILI). Specimens to be evaluated in this study will be enrolled in a concurrent clinical study per protocol FLU-05, entitled "Prospective Evaluation of the fluID Rapid Influenza Test". All subjects enrolled in the FLU-05 study will have consented to having their samples used in future investigations involving the fluID Test.
This study will be conducted during the 2008-2009 influenza season in North America and Hong Kong, which is anticipated to run from November 2008 to May 2009. Should the influenza season conclude in North America and Hong Kong prior to the attainment of the minimum target enrollment specified in the FLU-05 study, study sites in Australia will also be enlisted in order to enroll subjects; in such a case, enrollment will continue during the 2009 influenza season in these countries, which is anticipated to run from May through October, 2009.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects presenting to the investigative site within 4 days of symptom onset, with:
Written subject informed consent for this study protocol must be obtained prior to study enrollment. Each subject (or parent or guardian) must personally sign and date the Subject Informed Consent Form prior to his/her participation in this clinical study.
Exclusion Criteria:
United States, Louisiana | |
Louisiana State University Health Sciences Center | |
Shreveport, Louisiana, United States, 71103 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Responsible Party: | Nanogen, Inc. ( Philip Estes / Associate Director, Clinical ) |
Study ID Numbers: | FLU-13 |
Study First Received: | January 20, 2009 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00828100 History of Changes |
Health Authority: | United States: Institutional Review Board; Canada: Health Canada |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |