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Trial record 3 of 3148 for:    Indiana Health

A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay in Patients With Signs and Symptoms of Acute Gastroenteritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Luminex Molecular Diagnostics
Sponsor:
Information provided by (Responsible Party):
Luminex Molecular Diagnostics ( Luminex Corporation )
ClinicalTrials.gov Identifier:
NCT02092259
First received: March 17, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.

The purpose of this study is to establish the diagnostic accuracy of ARIES Norovirus Assay.


Condition
Acute Gastroenteritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay in Patients With Signs and Symptoms of Acute Gastroenteritis

Resource links provided by NLM:


Further study details as provided by Luminex Molecular Diagnostics:

Primary Outcome Measures:
  • Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement). [ Time Frame: Within the first year of sample collection ] [ Designated as safety issue: No ]
    Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by ARIES Norovirus Assay.


Biospecimen Retention:   Samples With DNA

Stool


Estimated Enrollment: 500
Study Start Date: January 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

The ARIES Norovirus Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.

The objective is to establish the diagnostic accuracy of the ARIES Norovirus assay through a multi-site, method comparison on prospectively collected leftover, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement)

  Eligibility

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

All comers

Criteria

Inclusion Criteria:

  • The specimen is from a patient with symptoms of acute gastroenteritis.
  • The specimen is from a male or female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic.
  • The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.

Exclusion Criteria:

  • The specimen is from an individual with known and documented non-infectious conditions such as ulcerative colitis, irritable bowel syndrome and/or Crohn's disease
  • The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.
  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: NCT02092259

Contacts
Contact: Ian Ridd iridd@luminexcorp.com

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90049
Contact: Janet Hindler       jhindler@mednet.ucla.edu   
Principal Investigator: Romney Humphries, Ph.D         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 13123
Contact: C. Robinson       Christine.Robinson@childrenscolorado.org   
Principal Investigator: Christine Robinson, Ph.D         
United States, Indiana
Indiana Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kristin Post       kpost@iuhealth.org   
Principal Investigator: Liang Cheng, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Elena Popowitch       elena.popowitch@unchealth.unc.edu   
Principal Investigator: Melissa Miller, Ph.D         
United States, Pennsylvania
Geisinger Medical Laboratories Recruiting
Danville, Pennsylvania, United States, 17822-0131
Contact: D. Hernandez       drhernandez@geisinger.edu   
Principal Investigator: Donna M Wolk, Ph.D.,D(ABMM)         
Sponsors and Collaborators
Luminex Corporation
Investigators
Study Director: David Himsworth Luminex Corporation
  More Information

No publications provided

Responsible Party: Luminex Molecular Diagnostics ( Luminex Corporation )
ClinicalTrials.gov Identifier: NCT02092259     History of Changes
Other Study ID Numbers: LMA-NOR-01-CS-001
Study First Received: March 17, 2014
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastroenteritis
Signs and Symptoms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014