Prospective Evaluation of the Fluid Rapid Influenza Test

This study has suspended participant recruitment.
(The 2008-09 North American peak influenza season ended prior to study completion.)
Sponsor:
Collaborator:
Information provided by:
Nanogen, Inc.
ClinicalTrials.gov Identifier:
NCT00826709
First received: January 20, 2009
Last updated: April 14, 2009
Last verified: April 2009
  Purpose

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).


Condition Intervention Phase
Influenza
Device: fluID Rapid Influenza Test
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: CLINICAL STUDY PROTOCOL for the Prospective Evaluation of the fluID Rapid Influenza Test

Resource links provided by NLM:


Further study details as provided by Nanogen, Inc.:

Primary Outcome Measures:
  • Sensitivity and specificity of influenza A and influenza B [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity and specificity of influenza A subtypes H1N1 and H3N2 [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1300
Study Start Date: February 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826709

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

No publications provided

Responsible Party: Philip Estes/Associate Director, Clinical, Nanogen, Inc.
ClinicalTrials.gov Identifier: NCT00826709     History of Changes
Other Study ID Numbers: FLU-05
Study First Received: January 20, 2009
Last Updated: April 14, 2009
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014