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Completed

NCT Number: NCT02068469

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.

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Key information

Conditions

Streptococcal Sore Throat

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Norwich Pediatrics, Norwich, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture

    Time frame: Results based on samples collected at initial visit

Sponsors and collaborators

Lead sponsor

IQuum, Inc.

Industry

Collaborators

  • Roche Molecular Systems, Inc

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 21, 2014
Registry last updated
Aug 31, 2016

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.

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