Prospective Evaluation of the Fluid Rapid Influenza Test

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

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).

Study Overview

• Status: Suspended
• Conditions: Influenza
• Intervention / Treatment: Device: fluID Rapid Influenza Test

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 Type: Interventional
• Enrollment (Anticipated): 1300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • University of Hong Kong
• United States
  • California
    • San Diego, California, United States, 92152
      • Naval Health Research Center
  • Florida
    • DeLand, Florida, United States, 32720
      • University Clinical Research - Deland, LLC
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Louisiana State University Health Sciences Center
    • Shreveport, Louisiana, United States, 71115
      • The Family Doctor Research
  • Michigan
    • Detroit, Michigan, United States, 48235
      • Sinai Grace Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
    • St. Louis, Missouri, United States, 63110
      • Washington University at St. Louis
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Methodist Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center
  • Utah
    • West Valley City, Utah, United States, 84015
      • Granger Medical Clinic
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 2 Nasal swabs	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).
Experimental: Arm 2; 2 Nasopharyngeal swabs	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).
Experimental: Arm 3; Nasal wash or aspirate	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of influenza A and influenza B	End of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of influenza A subtypes H1N1 and H3N2	End of study

Collaborators and Investigators

• Sponsor: Nanogen, Inc.
• Collaborators: Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Anticipated): October 1, 2009

Study Registration Dates

• First Submitted: January 20, 2009
• First Submitted That Met QC Criteria: January 21, 2009
• First Posted (Estimate): January 22, 2009

Study Record Updates

• Last Update Posted (Estimate): April 15, 2009
• Last Update Submitted That Met QC Criteria: April 14, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: FLU-05