Back to resultsPharyngitis,Group A Streptococcal Infection,Rapid Streptococcal Test,Throat Swab Culture
Primary Purpose
Pharyngitis
Status
Completed
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Rapid Immunochromatographic streptococcal test
Sponsored by
About this trial
This is an interventional diagnostic trial for Pharyngitis focused on measuring Group A streptococcal pharyngitis, Rapid streptococcal test, Throat swab culture
Eligibility Criteria
Inclusion Criteria:
- All patients presenting with the possible diagnosis of Bacterial pharyngitis,between 1-14 years of age.
Exclusion Criteria:
- Patients who received antibiotics within two weeks from presentation
Sites / Locations
- Hamad medical corporation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rapid Immunochromatographic Streptococcal test
Arm Description
Throat swabbing by two port germ Amines agar (copan) swabs,the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment.
Outcomes
Primary Outcome Measures
The ratio of true negative rapid immunochromatographic strep test when compared throat culture
Secondary Outcome Measures
The ratio of true positive rapid immunochromatographic strep test when compared to throat culture
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02494219
Brief Title
Pharyngitis,Group A Streptococcal Infection,Rapid Streptococcal Test,Throat Swab Culture
Official Title
Comparison of Immunochromatographic Test for Rapid Detection of Group A Streptococcal Antigen With Culture in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen with culture in Pediatric patients.
Detailed Description
Throat swabbing by two port germ Amines agar (copan) swabs,then the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis
Keywords
Group A streptococcal pharyngitis, Rapid streptococcal test, Throat swab culture
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
906 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapid Immunochromatographic Streptococcal test
Arm Type
Experimental
Arm Description
Throat swabbing by two port germ Amines agar (copan) swabs,the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment.
Intervention Type
Procedure
Intervention Name(s)
Rapid Immunochromatographic streptococcal test
Intervention Description
Throat swab obtained for rapid strep test in addition to throat culture,in order to check the accuracy of Rapid Immunochromatographic streptococcal test in detection of streptococcal pharyngitis
Primary Outcome Measure Information:
Title
The ratio of true negative rapid immunochromatographic strep test when compared throat culture
Time Frame
upto 48 hours
Secondary Outcome Measure Information:
Title
The ratio of true positive rapid immunochromatographic strep test when compared to throat culture
Time Frame
upto 48hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients presenting with the possible diagnosis of Bacterial pharyngitis,between 1-14 years of age.
Exclusion Criteria:
Patients who received antibiotics within two weeks from presentation
Facility Information:
Facility Name
Hamad medical corporation
City
Doha
ZIP/Postal Code
3050
Country
Qatar
12. IPD Sharing Statement
Learn more about this trial
Pharyngitis,Group A Streptococcal Infection,Rapid Streptococcal Test,Throat Swab Culture
We'll reach out to this number within 24 hrs