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NCT02494219 Clinical Trial

Pharyngitis,Group A Streptococcal Infection,Rapid Streptococcal Test,Throat Swab Culture

Pharyngitis Clinical Trial

Official title:
Comparison of Immunochromatographic Test for Rapid Detection of Group A Streptococcal Antigen With Culture in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02494219
Other study ID # HamadMC
Secondary ID
Status Completed
Phase N/A
First received June 18, 2015
Last updated July 7, 2015
Start date January 2008
Est. completion date December 2010

Study information
Verified date June 2015
Source Hamad Medical Corporation
Contact n/a
Is FDA regulated No
Health authority Qatar: Hamad Medical Corporation
Study type Interventional

Clinical Trial Summary

Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen with culture in Pediatric patients.

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.

Recruitment information / eligibility
Status Completed
Enrollment 906
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 14 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Rapid Immunochromatographic streptococcal test
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

Locations
Country Name City State
Qatar Hamad medical corporation Doha

Sponsors (1)
Lead Sponsor Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome
Type Measure Description Time frame Safety issue
Primary The ratio of true negative rapid immunochromatographic strep test when compared throat culture upto 48 hours Yes
Secondary The ratio of true positive rapid immunochromatographic strep test when compared to throat culture upto 48hours Yes
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