Sofia Strep A FIA Field Study | NCT01494792

Studies
Sofia Strep A FIA Field Study

NCT01494792

Sponsor

Quidel Corporation

Status

Terminated

Last Update Posted

Oct 10, 2012Estimated

Enrollment

2,090Actual

Phase

Not provided

Conditions

Group A Streptococcus
Strep Throat

Interventions

In Vitro Diagnositc aid for diagnosis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Performance did not meet sponsor requirements.

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Dec 15, 2011

First Submission Date that Met QC Criteria

Dec 16, 2011

First Posted Date

Dec 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2012

Last Update Posted Date

Oct 10, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,090Actual

Name	Type	Description	Arm Group Labels	Other Names
In Vitro Diagnositc aid for diagnosis	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
La Costa Pediatrics		Carlsbad	California	92009	United States
Santo Nino Medical Clinic

Intervention Browse Module

MeSH Terms

ID	Term
D003933	Diagnosis

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided