Recruiting

One Step Strep A vs. Culture

Sponsor:

IND Diagnostic Inc.

Code:

NCT01491776

Conditions

Strep Throat

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Study Details

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 Streptococcus (Strep A) when compared to culture.

Conditions

Strep Throat

Study ID

NCT01491776

Start date

Dec, 2011

Status verified date

Mar, 2012

Completion date

Apr, 2012

Anticipated

Primary completion date

Mar, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

315 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Locations

Pioneer Clinical Research, LLC

Recruiting

Bellevue, Nebraska, United States, 68005

Contacts

Andrea Goolsby, LPN-C, CCRC

402-291-8704agoolsby.pcr@gmail.com

Principal Investigator:

Darin M. Gregory, MD

HCCA Clinical Research

Recruiting

Franklin, Tennessee, United States, 37067

Contacts

Amie Demming

615-627-1018ademming@hccacrs.com

Principal Investigator:

Sreedhar (Steve) Samudrala, MD

HCCA Clinical Research

Recruiting

Smyrna, Tennessee, United States, 37067

Contacts

Amie Demming

615-627-1018ademming@hccacrs.com

Principal Investigator:

Sadia Dar, MD

More Information

Sponsor

IND Diagnostic Inc.

Last update posted

Mar 8, 2012

Last verified

Mar, 2012

Keywords

  • Group A Streptococcus
  • Strep A
  • Rapid Test
  • Pharyngitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IND Diagnostic Inc. on 2012-03-08.