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Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099018
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : April 17, 2017
Sponsor:
Collaborator:
Quidel Corporation
Information provided by (Responsible Party):
Laurence Lacroix, University Hospital, Geneva

Brief Summary:
Group A streptococcal (GAS) pharyngitis in children represents a frequent diagnostic challenge in pediatric emergency departments, since isolated signs and clinical prediction rules are insufficient to accurately discriminate between GAS and non GAS infections. Rapid antigen detection tests (RADTs) therefore remain essential, simple and rapid tools, allowing for rapid GAS identification and prompt antibiotic prescription. However, their sensitivity is not optimal. The aim of the present study is to test the accuracy of a new fluorescent immunoassay (Sofia Strep A FIA) using the optical technology for GAS detection in children 3-15 years old with pharyngitis, compared to a standard RADT, using throat culture as the gold standard (or PCR for discrepant results, i.e. negative culture with any positive RADT).

Condition or disease Intervention/treatment
Pharyngitis Diagnostic Test: Sofia Strep A FIA

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children
Actual Study Start Date : June 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Sofia Strep A FIA
    Patients who presented with sore throat will be performed throat swab for the new fluorescent immunoasssay (Sofia Strep A FIA), for a standard RADT (Alere Testpack Strep A) and for culture and backup PCR in case of discrepant results.


Primary Outcome Measures :
  1. Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis [ Time Frame: 1 hour ]
    Comparison of the sensitivity and specificity of two rapid tests (Sofia StrepA FIA and Alere Testpack Strep A) using standard throat culture as reference.


Secondary Outcome Measures :
  1. Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis stratified on the pretest probability of GAS infection (according to McIsaac scores) [ Time Frame: 1 hour ]
    sensitivity and specificity of the two tests in relationship to the pretest-probability of GAS infection as measured by the McIsaac score



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children 3 to 15 years old presenting to the PED with pharyngitis and Mc Isaac score ≥ 2
Criteria

Inclusion Criteria:

  • Patient age between 3 and 15 years
  • Clinical diagnosis of pharyngitis
  • McIsaac score ≥2

Exclusion Criteria:

  • Antibiotic treatment in the two weeks preceding the consultation

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): NCT03099018


Sponsors and Collaborators
University Hospital, Geneva
Quidel Corporation
Investigators
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Principal Investigator: Laurence Lacroix, MD University Hospital, Geneva
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Responsible Party: Laurence Lacroix, MD, Pediatric Emergency Physician, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03099018    
Other Study ID Numbers: 13-248
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Laurence Lacroix, University Hospital, Geneva:
GAS
pharyngitis
children
RADT
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases