- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02068469
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
Conditions
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
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Connecticut
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Norwich, Connecticut, United States, 06360
- Norwich Pediatrics
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Georgia
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Savannah, Georgia, United States, 31406
- Meridian Clinical Research
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New York
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Rochester, New York, United States, 14618
- Twelve Corners Pediatrics
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Texas
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Plano, Texas, United States, 75093
- Plano Pediatrics
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Virginia
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Vienna, Virginia, United States, 22180
- Advanced Pediatrics
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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
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- SASA 4.0
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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