Status:

UNKNOWN

Evaluation of the IND One Step Strep A Rapid Test vs. Culture

Lead Sponsor:

IND Diagnostic Inc.

Conditions:

Strep Throat

Eligibility:

All Genders

3+ years

Brief Summary

The purpose of this study is to demonstrate the ability of the IND One Step Strep A test to accurately test a throat swab specimen from a symptomatic patient for the presence or absence of Group A Str...

Detailed Description

Group A Streptococcus is a principal cause of respiratory infections such as tonsillitis, pharyngitis, and scarlet fever. Since pharyngitis can lead to rheumatic fever or acute glomerulonephritis, it ...

Eligibility Criteria

Inclusion

  • Male and Female subjects three (3) years of age or older
  • Patients exhibiting at least 3 of the following symptoms:
  • fever
  • sore throat
  • swollen lymph nodes in the neck
  • redness of the throat and tonsils
  • white or yellow patches on the tonsils
  • Must be able to collect 2 throat swab samples from patient

Exclusion

  • Patients currently undergoing antibiotic treatment will be excluded from study

Key Trial Info

Start Date :

December 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 1 2012

Estimated Enrollment :

315 Patients enrolled

Trial Details

Trial ID

NCT01491776

Start Date

December 1 2011

End Date

April 1 2012

Last Update

March 8 2012

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Pioneer Clinical Research, LLC

Bellevue, Nebraska, United States, 68005

2

HCCA Clinical Research

Franklin, Tennessee, United States, 37067

3

HCCA Clinical Research

Smyrna, Tennessee, United States, 37067