NCT01494792

Brief Summary

The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2,090

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
terminated

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

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

9 months

First QC Date

December 15, 2011

Last Update Submit

October 5, 2012

Conditions

Group A StreptococcusStrep Throat

Interventions

In Vitro Diagnositc aid for diagnosisDEVICE

Eligibility Criteria

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

Subjects must be three (3) years of age or older and exhibiting symptoms characteristics of pharyngitis, possibly Group A Streptococcus.

You may qualify if:

  • Presence of sore throat
  • Redness of the posterior pharyngeal wall
  • Tonsillar exudate
  • Tonsillar swelling
  • Tender anterior cervical adenopathy
  • Fever, \> 38º C (100.4ºF) at presentation or within past 24 hours
  • Other symptoms that may be present, in addition to above symptoms for GAS:
  • Rash, typical of scarlet fever
  • Abnormal tympanic membranes
  • Palatal petechiae

You may not qualify if:

  • Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study.
  • At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

La Costa Pediatrics

Carlsbad, California, 92009, United States

Location

Santo Nino Medical Clinic

Panorama City, California, 91402, United States

Location

La Jolla Pediatrics

San Diego, California, 92121, United States

Location

Teena Hughes, MD

Tampa, Florida, 33613, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614-3394, United States

Location

Twelve Corners Pediatrics

Rochester, New York, 14618, United States

Location

Montrose Family Practice

Akron, Ohio, 44333, United States

Location

Advanced Pediatrics

Vienna, Virginia, 22180, United States

Location

MeSH Terms

Interventions

Diagnosis

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 19, 2011

Study Start

November 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

US(8)