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Assessment of Flocked Swabs for the Identification of Group A Streptococcal Pharyngitis

Primary Purpose

Streptococcal Infection, Pharyngitis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Flocked swab
Sponsored by
Children's Hospital of Eastern Ontario
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Streptococcal Infection focused on measuring Flocked swab, Group A streptococcus pharyngitis

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Need for a bacterial throat culture

Sites / Locations

  • Children's Hospital of Eastern Ontario Emergency Department

Outcomes

Primary Outcome Measures

Identification of Group A streptococcus via culture of organism

Secondary Outcome Measures

Full Information

First Posted
September 10, 2007
Last Updated
April 17, 2018
Sponsor
Children's Hospital of Eastern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT00527852
Brief Title
Assessment of Flocked Swabs for the Identification of Group A Streptococcal Pharyngitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Hospital of Eastern Ontario

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a study to to compare traditional fibre wound swabs to more recently developed flocked swabs for the identification of Group A streptococcal pharyngitis in children presenting to a children's emergency department.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcal Infection, Pharyngitis
Keywords
Flocked swab, Group A streptococcus pharyngitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Flocked swab
Primary Outcome Measure Information:
Title
Identification of Group A streptococcus via culture of organism

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Need for a bacterial throat culture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Goldfarb, MD FRCPC
Organizational Affiliation
Children's Hospital of Eastern Ontario, Division of Infectious Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario Emergency Department
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Assessment of Flocked Swabs for the Identification of Group A Streptococcal Pharyngitis

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