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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03037957
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Luminex Molecular Diagnostics ( Luminex Corporation )

Brief Summary:
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.

Condition or disease Intervention/treatment
Pharyngitis Bacterial Device: ARIES Group A Strep Assay

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Study Type : Observational
Actual Enrollment : 704 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
Actual Study Start Date : January 9, 2017
Actual Primary Completion Date : June 2, 2017
Actual Study Completion Date : June 2, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Clinical performance (sensitivity/specificity) for Group A Strep Assay [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037957


Locations
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United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
United States, Florida
Sacred Heart Hospital
Pensacola, Florida, United States, 32504
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 54449
United States, Virginia
Advanced Pediatrics Research
Vienna, Virginia, United States, 22180
United States, Wisconsin
Marshfield Labs
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Luminex Corporation
Investigators
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Study Director: Ronald Dunn Luminex Corporation

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Responsible Party: Luminex Corporation
ClinicalTrials.gov Identifier: NCT03037957     History of Changes
Other Study ID Numbers: LMA-GAS-01-CS-006
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases