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NCT03099018 Clinical Trial

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

Pharyngitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03099018
Other study ID # 13-248
Secondary ID
Status Completed
Phase N/A
First received March 28, 2017
Last updated April 13, 2017
Start date June 2014
Est. completion date November 2016

Study information
Verified date April 2017
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 3 Years to 15 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Geneva Quidel Corporation

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis Comparison of the sensitivity and specificity of two rapid tests (Sofia StrepA FIA and Alere Testpack Strep A) using standard throat culture as reference. 1 hour
Secondary 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) sensitivity and specificity of the two tests in relationship to the pretest-probability of GAS infection as measured by the McIsaac score 1 hour
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