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Prospective Evaluation of the Fluid Rapid Influenza Test

Primary Purpose

Influenza

Status
Suspended
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
fluID Rapid Influenza Test
Sponsored by
Nanogen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Influenza

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Naval Health Research Center
  • University Clinical Research - DeLand, LLC
  • Louisiana State University Health Sciences Center
  • The Family Doctor Research
  • Sinai Grace Hospital
  • Hennepin County Medical Center
  • Children's Mercy Hospital
  • Washington University at St. Louis
  • New York Methodist Hospital
  • Forsyth Medical Center
  • Granger Medical Clinic
  • Medical College of Wisconsin
  • University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

2 Nasal swabs

2 Nasopharyngeal swabs

Nasal wash or aspirate

Outcomes

Primary Outcome Measures

Sensitivity and specificity of influenza A and influenza B

Secondary Outcome Measures

Sensitivity and specificity of influenza A subtypes H1N1 and H3N2

Full Information

First Posted
January 20, 2009
Last Updated
April 14, 2009
Sponsor
Nanogen, Inc.
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00826709
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Suspended
Why Stopped
The 2008-09 North American peak influenza season ended prior to study completion.
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Nanogen, Inc.
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
2 Nasal swabs
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
2 Nasopharyngeal swabs
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Nasal wash or aspirate
Intervention Type
Device
Intervention Name(s)
fluID Rapid Influenza Test
Intervention Description
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).
Primary Outcome Measure Information:
Title
Sensitivity and specificity of influenza A and influenza B
Time Frame
End of study
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of influenza A subtypes H1N1 and H3N2
Time Frame
End of study

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Naval Health Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92152
Country
United States
Facility Name
University Clinical Research - DeLand, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
The Family Doctor Research
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71115
Country
United States
Facility Name
Sinai Grace Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48235
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University at St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Granger Medical Clinic
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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Prospective Evaluation of the Fluid Rapid Influenza Test

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