Clinical Validation of the Point-of-Care MSD Influenza Test

This study is currently recruiting participants.

Verified by Meso Scale Diagnostics, LLC., March 2009

First Received: March 16, 2009 No Changes Posted

Sponsors and Collaborators:	Meso Scale Diagnostics, LLC. Centers for Disease Control and Prevention
Information provided by:	Meso Scale Diagnostics, LLC.
ClinicalTrials.gov Identifier:	NCT00863343

Purpose

The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).

Condition
Influenza Human

MedlinePlus related topics: Flu

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Clinical Validation of the Point-of-Care MSD Influenza Test

Further study details as provided by Meso Scale Diagnostics, LLC.:

Primary Outcome Measures:

Sensitivity and specificity of influenza A and influenza B, and influenza A subtypes A/H1 and A/H3. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Specificity of influenza subtype A/H5. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Viral transport media containing nasal swab extract.

Estimated Enrollment:	1000
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
All Anyone presenting with influenza-like-illness

Detailed Description:

This is a multicenter, prospective study to evaluate the performance of the MSD Influenza Test for the detection and differentiation of influenza A (including A/H1, A/H3, and A/H5 subtypes) and influenza B. Nasal swabs from subjects presenting at the clinical care facility with ILI will be collected and tested on the MSD Influenza Test. Results from the Test will be compared to results obtained from viral culture performed on a second nasal swab at a reference laboratory.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Individuals visiting a primary care site.

Criteria

Inclusion Criteria:

Any subject (all ages) presenting with ILI (defined as fever [subjective or documented] and cough or sore throat), and suspected of having influenza.
Subject (parent, guardian, or authorized legal representative) gives informed consent or assent (child) to the study, and provides signed authorization for use and disclosure of protected health information.

Exclusion Criteria:

Any subject classified as "high risk" for exposure to avian or novel influenza, as determined by a Risk-Assessment Questionnaire.
Subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863343

Locations

United States, California
Naval Health Research Center	Recruiting
San Diego, California, United States, 92106
Contact: Tabitha Zimmerman, MD 619-553-8634 tabitha.zimmerman@med.navy.mil
Principal Investigator: Dennis Faix, MD, MPH
United States, New Hampshire
Dartmouth-Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Tracy Ostler 603-650-4145 tracy.l.ostler@hitchcock.org
Principal Investigator: Henry Bernstein, DO
United States, New York
John T Mather Hospital	Recruiting
Port Jefferson, New York, United States, 11777
Contact: Denise Geiger, PhD,DLM-ASCP 631-473-1320 ext 4137 dgeiger@matherhospital.org
Principal Investigator: Denise Geiger, PhD,DLM-ASCP
United States, Tennessee
Vanderbilt University Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Karen Miller, RN,MPA,CCRC 615-936-4790 karen.f.miller@vanderbilt.edu
Principal Investigator: Alan Storrow, MD

Sponsors and Collaborators

Meso Scale Diagnostics, LLC.

Centers for Disease Control and Prevention

Investigators

Study Director:

Jacqueline Perodin, PhD, CCRP

Meso Scale Diagnostics

More Information

No publications provided

Responsible Party:	Meso Scale Diagnostics ( Jeff Debad/Director, Clinical )
Study ID Numbers:	MSD-ITPOC-01
Study First Received:	March 16, 2009
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00863343 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Meso Scale Diagnostics, LLC.:

Influenza infections
Orthomyxoviridae infections

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009