A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients

July 5, 2017 updated by: Luminex Corporation
A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

704

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
    • Florida
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Hospital
    • Missouri
      • Kansas City, Missouri, United States, 54449
        • Children's Mercy Hospital
    • Virginia
      • Vienna, Virginia, United States, 22180
        • Advanced Pediatrics Research
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Labs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting with signs and symptoms of pharyngitis for which their doctors ordered a Group A Strep test.

Description

Inclusion Criteria:

  • Patient and/or patient's legal guardian is willing and able to give informed consent and/or assent for extra research sample.
  • The subject's specimen is a throat swab in Liquid Amies based transport medium.
  • The specimen is from an adult or pediatric, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinical or resident of a long term care facility.
  • The specimen is from a patient for whom a requisition has been made for Group A Strep testing
  • The specimen is from a patient exhibiting clinical signs and symptoms of pharyngitis consistent with Group A Strep infection.
  • The specimen was received in good condition (no leakage or drying of the specimen).
  • The specimen volume is ≥ 850 µL.

Exclusion Criteria:

  • The specimen is from a patient who did not provide informed consent/assent.
  • The specimen is not a throat swab collected in Liquid Amies based transport medium.
  • The specimen is from a patient who is undergoing antibiotic treatment.
  • The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 9 below.
  • The specimen volume is < 850 µL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A Strep Assay
Device: ARIES Group A Strep Assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical performance (sensitivity/specificity) for Group A Strep Assay
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luminex Corporation

Investigators

  • Study Director: Ronald Dunn, Luminex Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2017

Primary Completion (Actual)

June 2, 2017

Study Completion (Actual)

June 2, 2017

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 27, 2017

First Posted (Estimate)

January 31, 2017

Study Record Updates

Last Update Posted (Actual)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMA-GAS-01-CS-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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