Comparison of Fluid Rapid Influenza and BinaxNOW Influenza A & B

Tracking Information
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; (submitted: January 22, 2009)	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.
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
Condition ICMJE	Influenza
Intervention ICMJE	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) setting.; Device: BinaxNOW® Influenza A & B The BinaxNOW Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by culture.
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.
Recruitment Information
Recruitment Status ICMJE	Suspended
Estimated Enrollment ICMJE; (submitted: January 22, 2009)	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: Male or female subjects of any age;; Subjects presenting to the investigative site within 4 days of symptom onset, with: Fever ≥ 38.0°C (100.4°F) if taken orally, or ≥ 38.5°C (101.2°F) if taken rectally; or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever; One or more respiratory symptoms of influenza-like illness which may include the following: Sore throat Runny or stuffy nose Cough One or more constitutional symptoms of influenza-like illness which may include the following: Myalgia (aches and pains) Headache Fatigue; Subjects (or parent/guardian) willing and able to provide informed consent;; Subjects must be enrolled in Arm 3 of the FLU-05 clinical study. 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: Subjects not presenting with at least three symptoms of influenza-like illness as outlined above.; Subjects who have received influenza antiviral medication or an investigational influenza drug treatment within the previous 30 days of study enrollment.; Subjects (children and adults) for whom the obtaining of aspirate samples is contraindicated or not possible.; Subjects with a medical condition that prevents nasal washes or aspirate samples from being obtained.; Active duty military personnel (participating military study sites only).; Subjects (or parent/guardian) unwilling or unable to provide informed consent.
Sex/Gender	Sexes Eligible for Study: All
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