Prospective Evaluation of the Fluid Rapid Influenza Test

Influenza Clinical Trial

Official title:

CLINICAL STUDY PROTOCOL for the Prospective Evaluation of the fluID Rapid Influenza Test

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00826709
• Other study ID #: FLU-05
• Status: Suspended
• Phase: Phase 3
• First received: January 20, 2009
• Last updated: April 14, 2009
• Start date: February 2009

Study information

• Verified date: April 2009
• Source: Nanogen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 1300
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Male or female subjects of any age;

2. 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;

3. 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:

1. Subjects not presenting with at least three symptoms of influenza-like illness as outlined above.

2. Subjects who have received influenza antiviral medication or an investigational influenza drug treatment within the previous 30 days of study enrollment.

3. Subjects (children and adults) for whom the obtaining of swab samples, nasal wash or aspirate samples is contraindicated or not possible.

4. Subjects with a medical condition that prevents swab samples or nasal washes or aspirate samples from being obtained.

5. Active duty military personnel (participating military study sites only).

6. Subjects (or parent/guardian) unwilling or unable to provide informed consent.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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).

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong
United States	New York Methodist Hospital	Brooklyn	New York
United States	University Clinical Research - DeLand, LLC	DeLand	Florida
United States	Sinai Grace Hospital	Detroit	Michigan
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Naval Health Research Center	San Diego	California
United States	Louisiana State University Health Sciences Center	Shreveport	Louisiana
United States	The Family Doctor Research	Shreveport	Louisiana
United States	Washington University at St. Louis	St. Louis	Missouri
United States	Granger Medical Clinic	West Valley City	Utah
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Nanogen, Inc.	Centers for Disease Control and Prevention

Countries where clinical trial is conducted

United States,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of influenza A and influenza B		End of study	No
Secondary	Sensitivity and specificity of influenza A subtypes H1N1 and H3N2		End of study	No