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

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ClinicalTrials.gov Identifier: NCT02494219
Recruitment Status : Completed
First Posted : July 10, 2015
Last Update Posted : July 10, 2015
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation

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

Condition or disease Intervention/treatment Phase
Pharyngitis Procedure: Rapid Immunochromatographic streptococcal test Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 906 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Immunochromatographic Test for Rapid Detection of Group A Streptococcal Antigen With Culture in Pediatric Patients
Study Start Date : January 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010


Arm Intervention/treatment
Experimental: Rapid Immunochromatographic Streptococcal test
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.
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




Primary Outcome Measures :
  1. The ratio of true negative rapid immunochromatographic strep test when compared throat culture [ Time Frame: upto 48 hours ]

Secondary Outcome Measures :
  1. The ratio of true positive rapid immunochromatographic strep test when compared to throat culture [ Time Frame: upto 48hours ]


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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494219


Locations
Qatar
Hamad medical corporation
Doha, Qatar, 3050
Sponsors and Collaborators
Hamad Medical Corporation

Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT02494219     History of Changes
Other Study ID Numbers: HamadMC
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: July 10, 2015
Last Verified: June 2015

Keywords provided by Hamad Medical Corporation:
Group A streptococcal pharyngitis
Rapid streptococcal test
Throat swab culture

Additional relevant MeSH terms:
Pharyngitis
Streptococcal Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections