NCT02092259

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

July 14, 2015

Status Verified

June 1, 2015

Enrollment Period

1.9 years

First QC Date

March 17, 2014

Last Update Submit

July 10, 2015

Conditions

Acute Gastroenteritis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

    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.

    Within the first year of sample collection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All comers

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UCLA

Los Angeles, California, 90049, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 13123, United States

RECRUITING

Indiana Health

Indianapolis, Indiana, 46202, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Geisinger Medical Laboratories

Danville, Pennsylvania, 17822-0131, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool

Study Officials

  • David Himsworth

    Luminex Corporation

    STUDY DIRECTOR

Central Study Contacts

Ian Ridd

CONTACT

iridd@luminexcorp.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 20, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Last Updated

July 14, 2015

Record last verified: 2015-06

Locations

US(5)