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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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