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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by IND Diagnostic Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
IND Diagnostic Inc.
ClinicalTrials.gov Identifier:
NCT01491776
First received: December 12, 2011
Last updated: March 7, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by IND Diagnostic Inc.:

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)
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 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
Study Population

Male and female subjects, 3 years of age or older, exhibiting symptoms consistent with Strep A infection.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491776

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         
Sponsors and Collaborators
IND Diagnostic Inc.
Investigators
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 September 18, 2014