In Vitro Diagnostic Device for the Detection of Strep A

August 30, 2016 updated by: IQuum, Inc.

Multi-Center Study of an In Vitro Diagnostic Device for the Detection of Strep A

The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and assay for detecting Strep A at the point of care lab compared to culture.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

799

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

    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Norwich Pediatrics
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research
    • New York
      • Rochester, New York, United States, 14618
        • Twelve Corners Pediatrics
    • Texas
      • Plano, Texas, United States, 75093
        • Plano Pediatrics
    • Virginia
      • Vienna, Virginia, United States, 22180
        • Advanced Pediatrics

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

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult and Pediatric primary care clinic, walk in clinic

Description

Inclusion Criteria:

  • Subjects who are 3 years of age or older
  • Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A, including:

    • presence of sore throat, and at least one other symptom from the list below:
    • redness of the posterior pharyngeal wall
    • pharyngeal or tonsillar exudate
    • tonsillar swelling
    • tender cervical lymphadenopathy
    • fever, >38C at presentation or within the past 24 hours
  • Subjects who are able to understand and consent to participation; for minors under the age of 18, this includes parent or legal guardian

Exclusion Criteria:

  • Subjects treated with antibiotics currently or within the previous 7 days.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture
Time Frame: Results based on samples collected at initial visit
Results based on samples collected at initial visit

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Lingjun Chen, BS, IQuum COO

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

December 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 21, 2014

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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