Prospective Evaluation of the Fluid Rapid Influenza Test - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	January 20, 2009
Last Updated Date	April 14, 2009
Start Date ^†	February 2009
Current Primary Outcome Measures ^† (submitted: January 21, 2009)	Sensitivity and specificity of influenza A and influenza B [ Time Frame: End of study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00826709 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: January 21, 2009)	Sensitivity and specificity of influenza A subtypes H1N1 and H3N2 [ Time Frame: End of study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	Prospective Evaluation of the Fluid Rapid Influenza Test
Official Title ^†	CLINICAL STUDY PROTOCOL for the Prospective Evaluation of the fluID Rapid Influenza Test
Brief Summary	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).
Detailed Description	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.
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^†	Influenza
Intervention ^†	Device: fluID Rapid Influenza Test
Study Arms / Comparison Groups	Experimental: 2 Nasal swabs Experimental: 2 Nasopharyngeal swabs Experimental: Nasal wash or aspirate
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Suspended
Estimated Enrollment ^†	1300
Completion Date
Estimated Primary Completion Date	October 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	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. 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 swab samples, nasal wash or aspirate samples is contraindicated or not possible. Subjects with a medical condition that prevents swab samples or 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.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Hong Kong
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00826709
Responsible Party	Philip Estes/Associate Director, Clinical, Nanogen, Inc.
Secondary IDs ^††
Study Sponsor ^†	Nanogen, Inc.
Collaborators ^††	Centers for Disease Control and Prevention
Investigators ^†
Information Provided By	Nanogen, Inc.
Verification Date	April 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.