NCT02153008

Brief Summary

To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,708

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

May 29, 2014

Last Update Submit

August 1, 2017

Conditions

Group A Streptococcus

Keywords

Strep throat

Outcome Measures

Primary Outcomes (1)

  • Detection of Group A Streptococcus

    A throat swab specimen will be obtained and tested for the presence of Group A Streptococcus via the Sofia Analyzer

    Within 5 minutes

Study Arms (1)

Symptomatic population for GAS

This study is a diagnostic study to aid in the detection of Strep throat. No intervention or medication is a part of this study.

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from the general population as they present to the clinical facility. Subjects must be exhibiting symptoms characteristic of pharyngitis, possibly GAS.

You may qualify if:

  • Male and Female, 3 years of age or older
  • For example:
  • Acute onset of sore throat
  • Redness of the posterior pharyngeal wall
  • Difficulty/pain on swallowing
  • Fever, \> 37.8º C (100ºF) at presentation or within past 24 hours
  • Pharyngeal exudate
  • Tender cervical lymphadenopathy
  • Absence of cough, runny nose or other upper respiratory symptoms.\*
  • Other, symptoms specific to Strep A not listed above.

You may not qualify if:

  • Subjects currently under treatment with antibiotics are not to be included in this study.
  • At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Best Medical Group, LLC

Phoenix, Arizona, 85042-6510, United States

Location

Gentle Medical Associates

Boynton Beach, Florida, 33435, United States

Location

Pediatrics by the Sea

Delray Beach, Florida, 33483, United States

Location

Teena Hughes, MD

Tampa, Florida, 33613, United States

Location

Twelve Corners Pediatrics

Rochester, New York, 14618, United States

Location

Veritas, PA

Belton, Texas, 76513, United States

Location

Advanced Pediatrics

Vienna, Virginia, 22180, United States

Location

Study Officials

  • John D. Tamerius, PhD

    Quidel Corporation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 2, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 3, 2017

Record last verified: 2017-08

Locations

US(7)