Evaluation of the IND One Step Strep A Rapid Test vs. Culture
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Purpose
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.
| Condition |
|---|
|
Strep Throat |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of the IND One Step Strep A Rapid Test Versus Culture Using Clinical Throat Swab Samples From Patients With Suspected Strep A Infections, CLIA Waiver Study |
| Estimated Enrollment: | 315 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
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 is important to differentiate streptococcal pharyngitis from viral disease during early stages of infection. The Strep A Rapid Test is a simple and rapid test which can detect Group A Streptococcal antigen directly from throat swabs allowing physicians to make a rapid diagnosis and to administer therapy immediately. The IND Diagnostic Inc. Strep A Rapid Test is a lateral flow immunoassay utilizing colloidal gold reagents labeled with Strep A antibody. The test detects either viable or nonviable organisms directly from throat swabs within 10 minutes.
Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Male and female subjects, 3 years of age or older, exhibiting symptoms consistent with Strep A infection.
Inclusion Criteria:
- 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 Criteria:
- Patients currently undergoing antibiotic treatment will be excluded from study
Contacts and Locations| United States, Nebraska | |
| Pioneer Clinical Research, LLC | Recruiting |
| Bellevue, Nebraska, United States, 68005 | |
| Contact: Andrea Goolsby, LPN-C, CCRC 402-291-8704 agoolsby.pcr@gmail.com | |
| Principal Investigator: Darin M. Gregory, MD | |
| United States, Tennessee | |
| HCCA Clinical Research | Recruiting |
| Franklin, Tennessee, United States, 37067 | |
| Contact: Amie Demming 615-627-1018 ademming@hccacrs.com | |
| Principal Investigator: Sreedhar (Steve) Samudrala, MD | |
| HCCA Clinical Research | Recruiting |
| Smyrna, Tennessee, United States, 37067 | |
| Contact: Amie Demming 615-627-1018 ademming@hccacrs.com | |
| Principal Investigator: Sadia Dar, MD | |
| Principal Investigator: | Darin M. Gregory, MD | Pioneer Clinical Research |
| Principal Investigator: | Sadia Dar, MD | HCCA Clinical Research |
| Principal Investigator: | Sreedhar (Steve) Samudrala, MD | HCCA Clinical Research |
More Information
No publications provided
| Responsible Party: | IND Diagnostic Inc. |
| ClinicalTrials.gov Identifier: | NCT01491776 History of Changes |
| Other Study ID Numbers: | IND-CSP-2011-01 |
| Study First Received: | December 12, 2011 |
| Last Updated: | March 7, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by IND Diagnostic Inc.:
|
Group A Streptococcus Strep A Rapid Test Pharyngitis |
Additional relevant MeSH terms:
|
Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 16, 2013