Skip to main content
OpenTrials
Completed

NCT Number: NCT02153008

Strep A FIA Field Study, Sofia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Group A Streptococcus

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Best Medical Group, LLC, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and Female, 3 years of age or older
  • Must currently be exhibiting one or more of the symptoms characteristic of pharyngitis to be eligible for inclusion in this study.

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.
  • Must include at least one additional symptom from a-f and cannot be the only criteria used to meet inclusion for enrollment in the study.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Detection of Group A Streptococcus

    Time frame: Within 5 minutes

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

Sponsors and collaborators

Lead sponsor

Quidel Corporation

Industry

Registry information

Official study title

Sofia Strep A FIA Field Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 2, 2014
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.