Prospective Evaluation of the Fluid Rapid Influenza Test

NCT00826709 | Suspended Phase 3

• 1 other identifier: FLU-05
• Study Type: interventional
• Target: 1,300
• Locations: 2 countries
• Sites: 13

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).

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of influenza A and influenza B

  End of study

Secondary Outcomes (1)

• Sensitivity and specificity of influenza A subtypes H1N1 and H3N2

  End of study

Study Arms (3)

Arm 1

EXPERIMENTAL

2 Nasal swabs

Device: fluID Rapid Influenza Test

Arm 2

EXPERIMENTAL

2 Nasopharyngeal swabs

Device: fluID Rapid Influenza Test

Arm 3

EXPERIMENTAL

Nasal wash or aspirate

Device: fluID Rapid Influenza Test

Interventions

fluID Rapid Influenza Test DEVICE

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).

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanogen, Inc.: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (13)

Naval Health Research Center

San Diego, California, 92152, United States

Location

University Clinical Research - DeLand, LLC

DeLand, Florida, 32720, United States

Location

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

The Family Doctor Research

Shreveport, Louisiana, 71115, United States

Location

Sinai Grace Hospital

Detroit, Michigan, 48235, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Washington University at St. Louis

St Louis, Missouri, 63110, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Granger Medical Clinic

West Valley City, Utah, 84015, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 22, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2009
• Last Updated: April 15, 2009

Record last verified: 2009-04

Locations

HK (1); US (12)