Comparison of Fluid Rapid Influenza and BinaxNOW Influenza A & B
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ClinicalTrials.gov Identifier: NCT00828100 |
Recruitment Status
:
Suspended
(Study currently suspended due to a lack of available funding.)
First Posted
: January 23, 2009
Last Update Posted
: March 6, 2009
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Tracking Information | |||
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First Submitted Date ICMJE | January 20, 2009 | ||
First Posted Date ICMJE | January 23, 2009 | ||
Last Update Posted Date | March 6, 2009 | ||
Study Start Date ICMJE | February 2009 | ||
Estimated Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Positive percent agreement and negative percent agreement for both influenza A and influenza B. [ Time Frame: End of study ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | Complete list of historical versions of study NCT00828100 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Comparison of Fluid Rapid Influenza and BinaxNOW Influenza A & B | ||
Official Title ICMJE | Comparison of fluID Rapid Influenza and BinaxNOW® Influenza A & B | ||
Brief Summary | 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. | ||
Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Influenza | ||
Intervention ICMJE |
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Study Arms | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Suspended | ||
Estimated Enrollment ICMJE |
650 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Study Completion Date | Not Provided | ||
Estimated Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
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:
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Sex/Gender |
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Ages | Child, Adult, Senior | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00828100 | ||
Other Study ID Numbers ICMJE | FLU-13 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Philip Estes / Associate Director, Clinical, Nanogen, Inc. | ||
Study Sponsor ICMJE | Nanogen, Inc. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Nanogen, Inc. | ||
Verification Date | March 2009 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |