A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
1 other identifier
observational
704
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2017
CompletedStudy Start
First participant enrolled
January 9, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2017
CompletedJuly 7, 2017
July 1, 2017
5 months
January 3, 2017
July 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical performance (sensitivity/specificity) for Group A Strep Assay
Day 1
Study Arms (1)
Group A Strep Assay
Interventions
Eligibility Criteria
Patients presenting with signs and symptoms of pharyngitis for which their doctors ordered a Group A Strep test.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Children's Mercy Hospital
Kansas City, Missouri, 54449, United States
Advanced Pediatrics Research
Vienna, Virginia, 22180, United States
Marshfield Labs
Marshfield, Wisconsin, 54449, United States
Study Officials
- STUDY DIRECTOR
Ronald Dunn
Luminex Corporation
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2017
First Posted
January 31, 2017
Study Start
January 9, 2017
Primary Completion
June 2, 2017
Study Completion
June 2, 2017
Last Updated
July 7, 2017
Record last verified: 2017-07