Prospective Evaluation of the Fluid Rapid Influenza Test

Phase 3

Suspended

• Conditions: Influenza
• Interventions: Device: fluID Rapid Influenza Test

• Registration Number: NCT00826709
• Lead Sponsor: Nanogen, Inc.

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 Timeline

• Study First Submitted: 2009-01-20
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Study Start: 2009-02
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-14
• Last Update Posted: 2009-04-15
• Primary Completion: 2009-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 1300

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	fluID Rapid Influenza Test	2 Nasal swabs
Arm 2	fluID Rapid Influenza Test	2 Nasopharyngeal swabs
Arm 3	fluID Rapid Influenza Test	Nasal wash or aspirate

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of influenza A and influenza B	End of study

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of influenza A subtypes H1N1 and H3N2	End of study

Trial Locations

Locations (13)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

University Clinical Research - DeLand, LLC; 🇺🇸 DeLand, Florida, United States

The Family Doctor Research; 🇺🇸 Shreveport, Louisiana, United States

Naval Health Research Center; 🇺🇸 San Diego, California, United States

Sinai Grace Hospital; 🇺🇸 Detroit, Michigan, United States

Granger Medical Clinic; 🇺🇸 West Valley City, Utah, United States

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

New York Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

Washington University at St. Louis; 🇺🇸 St. Louis, Missouri, United States

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Louisiana State University Health Sciences Center; 🇺🇸 Shreveport, Louisiana, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong