NCT01491776

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

3 months

First QC Date

December 12, 2011

Last Update Submit

March 7, 2012

Conditions

Strep Throat

Keywords

Group A StreptococcusStrep ARapid TestPharyngitis

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pioneer Clinical Research, LLC

Bellevue, Nebraska, 68005, United States

RECRUITING

HCCA Clinical Research

Franklin, Tennessee, 37067, United States

RECRUITING

HCCA Clinical Research

Smyrna, Tennessee, 37067, United States

RECRUITING

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Darin M. Gregory, MD

    Pioneer Clinical Research

    PRINCIPAL INVESTIGATOR

  • Sadia Dar, MD

    HCCA Clinical Research

    PRINCIPAL INVESTIGATOR

  • Sreedhar (Steve) Samudrala, MD

    HCCA Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 14, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

US(3)