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Sponsors and Collaborators: |
Nanogen, Inc. Centers for Disease Control and Prevention |
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Information provided by: | Nanogen, Inc. |
ClinicalTrials.gov Identifier: | NCT00826709 |
The primary objective of this study is to evaluate the fluID Rapid Influenza Test's ability in detecting influenza A and influenza B from individuals presenting with signs and symptoms of influenza-like illness (ILI).
Condition | Intervention | Phase |
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Influenza |
Device: fluID Rapid Influenza Test |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | CLINICAL STUDY PROTOCOL for the Prospective Evaluation of the fluID Rapid Influenza Test |
Estimated Enrollment: | 1300 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental
2 Nasal swabs
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Device: fluID Rapid Influenza Test
The fluID™ Rapid Influenza Test is an in vitro diagnostic assay designed to be used with a reader for the qualitative detection of influenza type A and type B nucleoprotein antigens, and the differentiation of influenza type A subtypes A/H1 and A/H3 antigens associated with the seasonal influenza H1N1 and H3N2, in nasal swabs, nasopharyngeal swabs and nasal wash/aspirate specimens. The test is intended as an aid in the rapid, qualitative diagnosis of influenza type A and type B viral infections in patients symptomatic with influenza-like illness. The fluID™ Rapid Influenza Test is intended for use by a healthcare professional in a laboratory or Point-of-Care (POC).
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Arm 2: Experimental
2 Nasopharyngeal swabs
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Device: fluID Rapid Influenza Test
The fluID™ Rapid Influenza Test is an in vitro diagnostic assay designed to be used with a reader for the qualitative detection of influenza type A and type B nucleoprotein antigens, and the differentiation of influenza type A subtypes A/H1 and A/H3 antigens associated with the seasonal influenza H1N1 and H3N2, in nasal swabs, nasopharyngeal swabs and nasal wash/aspirate specimens. The test is intended as an aid in the rapid, qualitative diagnosis of influenza type A and type B viral infections in patients symptomatic with influenza-like illness. The fluID™ Rapid Influenza Test is intended for use by a healthcare professional in a laboratory or Point-of-Care (POC).
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Arm 3: Experimental
Nasal wash or aspirate
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Device: fluID Rapid Influenza Test
The fluID™ Rapid Influenza Test is an in vitro diagnostic assay designed to be used with a reader for the qualitative detection of influenza type A and type B nucleoprotein antigens, and the differentiation of influenza type A subtypes A/H1 and A/H3 antigens associated with the seasonal influenza H1N1 and H3N2, in nasal swabs, nasopharyngeal swabs and nasal wash/aspirate specimens. The test is intended as an aid in the rapid, qualitative diagnosis of influenza type A and type B viral infections in patients symptomatic with influenza-like illness. The fluID™ Rapid Influenza Test is intended for use by a healthcare professional in a laboratory or Point-of-Care (POC).
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The primary objective of this study is to evaluate the clinical sensitivity and specificity of the fluID Rapid Influenza Test in detecting influenza A and influenza B, as evaluated with respect to fresh samples collected prospectively from individuals presenting with signs and symptoms of influenza-like illness (ILI). Test results will be compared with those obtained from viral culture testing of samples using the same specimen types, obtained from the same subjects. The specimen types under evaluation in this study will be nasal swab, nasopharyngeal swab, nasal wash and aspirate specimens.
A secondary objective of this study is to evaluate the accuracy of the fluID Rapid Influenza Test in detecting each of the H1 and H3 subtypes of influenza A, in nasal swab, nasopharyngeal swab, nasal wash and aspirate specimens.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects presenting to the investigative site within 4 days of symptom onset, with:
Exclusion Criteria:
United States, California | |
Naval Health Research Center | |
San Diego, California, United States, 92152 | |
United States, Florida | |
University Clinical Research - DeLand, LLC | |
DeLand, Florida, United States, 32720 | |
United States, Louisiana | |
The Family Doctor Research | |
Shreveport, Louisiana, United States, 71115 | |
Louisiana State University Health Sciences Center | |
Shreveport, Louisiana, United States, 71103 | |
United States, Michigan | |
Sinai Grace Hospital | |
Detroit, Michigan, United States, 48235 | |
United States, Minnesota | |
Hennepin County Medical Center | |
Minneapolis, Minnesota, United States, 55415 | |
United States, Missouri | |
Children's Mercy Hospital | |
Kansas City, Missouri, United States, 64108 | |
Washington University at St. Louis | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
New York Methodist Hospital | |
Brooklyn, New York, United States, 11215 | |
United States, North Carolina | |
Forsyth Medical Center | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Utah | |
Granger Medical Clinic | |
West Valley City, Utah, United States, 84015 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 | |
Hong Kong | |
University of Hong Kong | |
Hong Kong, Hong Kong |
Responsible Party: | Nanogen, Inc. ( Philip Estes/Associate Director, Clinical ) |
Study ID Numbers: | FLU-05 |
Study First Received: | January 20, 2009 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00826709 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 |