Clinical trials›Pharyngitis Bacterial›Lifestyle›Trial details
FinishedObservation Study

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

For Condition: Pharyngitis Bacterial

ID: NCT03037957

Horizon Patient Guidance Summary

Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:

How it’s taken
Diet & Lifestyle / Therapy Care
Expected Availability Horizon
General pipeline timeline
StageGeneral evaluation study exploring treatment methods.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial

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 Timeline & Quick Facts
Trial Status
Study Finished
Total Target Enrollment
704 patients (Actual)
Study Start Date
2017-01-09
Est. Primary Completion
2017-06-02
Tested Drugs & Treatment Groups
DEVICEARIES Group A Strep Assay

Treatment Arms Description

ARM GROUPGroup A Strep Assay
Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
No age restriction
Full Criteria Checklist
Who Can Join
  • 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.
Who Cannot Join
  • 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.
What is this Study Measuring?

Primary Outcome Measures

  • Clinical performance (sensitivity/specificity) for Group A Strep Assay — Time Frame: Day 1
Where to Participate

This trial is recruiting at 5 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 5 Facilities & Contact Sites
Children's Hospital Los Angeles
Los Angeles, California, United States
Sacred Heart Hospital
Pensacola, Florida, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Advanced Pediatrics Research
Vienna, Virginia, United States
Marshfield Labs
Marshfield, Wisconsin, United States
Sponsoring Teams & Contacts
Lead Sponsoring Institution
Luminex Corporation
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View Official Medical/Scientific Title

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