In Vitro Diagnostic Device for the Detection of Strep A

Streptococcal Sore Throat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068469
• Other study ID #: SASA 4.0
• Status: Completed
• Phase: N/A
• First received: February 14, 2014
• Last updated: August 30, 2016
• Start date: December 2013
• Est. completion date: April 2014

Study information

• Verified date: August 2016
• Source: IQuum, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 799
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pharyngitis
• Streptococcal Sore Throat

Locations

Country	Name	City	State
United States	Norwich Pediatrics	Norwich	Connecticut
United States	Plano Pediatrics	Plano	Texas
United States	Twelve Corners Pediatrics	Rochester	New York
United States	Meridian Clinical Research	Savannah	Georgia
United States	Advanced Pediatrics	Vienna	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
IQuum, Inc.	Roche Molecular Systems, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture		Results based on samples collected at initial visit	No