Residual Sample Collection for Respiratory Viral Panel

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by GenMark Diagnostics
Sponsor:
Information provided by (Responsible Party):
GenMark Diagnostics
ClinicalTrials.gov Identifier:
NCT02049918
First received: January 23, 2014
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

Collect de-identified, residual samples to support a clinical trial. Samples may be prospectively or retrospectively collected. Overall Study Objective Obtain clinical performance data to characterize clinical performance of the Respiratory Viral Panel on the GenMark Sample-to-Answer Platform.


Condition
Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: De-identified Residual Sample Collection for the Respiratory Viral Panel on the GenMark Sample to Answer Platform (ARM 1)

Resource links provided by NLM:


Further study details as provided by GenMark Diagnostics:

Primary Outcome Measures:
  • Percentage of patient specimens that test positive by new test method vs. those that test positive by the gold standard method e.g., Culture [ Time Frame: One year from collection and culture testing to testing by new test method. ] [ Designated as safety issue: No ]
    This is an IVD Diagnostic study.


Biospecimen Retention:   Samples With DNA

Nasopharyngeal Swab


Estimated Enrollment: 1500
Study Start Date: November 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of this investigational study is to collect clinical samples to establish the clinical performance characteristics of the in vitro diagnostic (IVD) Respiratory Viral Panel on the GenMark Sample-to-Answer Platform. Data obtained from the samples will be used to support premarket submissions/registrations for this GenMark product. Samples will be aliquotted, characterized by comparator methods and banked until the instrument and assay are available for testing.

Sample collection may be prospective or retrospective. Prospective collection will preserve prevalence. Retrospective collection will be used to obtain sufficient numbers of certain sample types such as where the organism of interest is of low prevalence. The Sponsor will ensure that information identifying samples as prospectively or retrospectively collected is documented.

  Eligibility

Ages Eligible for Study:   up to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children and adults of any age suspected of having respiratory infection.

Criteria

Inclusion Criteria:

  • Sample from patients exhibiting signs/symptoms of respiratory viral infection

Exclusion Criteria:

  • Samples that are incorrectly de-identified
  • Samples that are received from sites incorrectly frozen or thawed.
  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: NCT02049918

Contacts
Contact: Jacqueline M Weir (760) 913-3242 jacqueline.weir@genmarkdx.com
Contact: Loralie R Yzerman, RN BScN (760) 448-4314 loralie.yzerman@genmarkdx.com

Locations
United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Wallace Greene, PhD         
Contact: Julie Vallati, LPN    :717-531-7047      
Principal Investigator: Wallace Greene, Phd         
Sponsors and Collaborators
GenMark Diagnostics
Investigators
Principal Investigator: Wallace Green, PhD Milton S. Hershey Medical Center
Principal Investigator: Tony Mazzulli, MD, FRCPC, FACP Mount Sinai Hospital, Canada
Principal Investigator: Michelle Fennell, MHA, MT(ASCP) Ingalls Memorial Hospital
  More Information

No publications provided

Responsible Party: GenMark Diagnostics
ClinicalTrials.gov Identifier: NCT02049918     History of Changes
Other Study ID Numbers: CTP0006
Study First Received: January 23, 2014
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by GenMark Diagnostics:
Respiratory viruses

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

ClinicalTrials.gov processed this record on August 27, 2014