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

Status unconfirmed

Conditions studied: Strep Throat

In brief

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 Streptococcus (Strep A) when compared to culture.

Key facts

Study ID

NCT01491776

Run by

IND Diagnostic Inc.

People needed

315

Starts

2011-12-01

Expected to finish

2012-04-01

Last updated by the study team

2012-03-08

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients currently undergoing antibiotic treatment will be excluded from study

Where it is running

• Pioneer Clinical Research, LLC — Bellevue, Nebraska, United States (enrolling)
• HCCA Clinical Research — Franklin, Tennessee, United States (enrolling)
• HCCA Clinical Research — Smyrna, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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