Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-03 @ 4:14 AM
Study NCT ID:
NCT03099018
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2017-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-13', 'studyFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2017-03-31', 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis', 'timeFrame': '1 hour', 'description': 'Comparison of the sensitivity and specificity of two rapid tests (Sofia StrepA FIA and Alere Testpack Strep A) using standard throat culture as reference.'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': '1 hour', 'description': 'sensitivity and specificity of the two tests in relationship to the pretest-probability of GAS infection as measured by the McIsaac score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GAS', 'pharyngitis', 'children', 'RADT'], 'conditions': ['Pharyngitis']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children 3 to 15 years old presenting to the PED with pharyngitis and Mc Isaac score ≥ 2', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age between 3 and 15 years\n* Clinical diagnosis of pharyngitis\n* McIsaac score ≥2\n\nExclusion Criteria:\n\n* Antibiotic treatment in the two weeks preceding the consultation'}, 'identificationModule': {'nctId': 'NCT03099018', 'briefTitle': 'Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Comparison of Two Rapid Antigen Detection Tests for the Detection of Group-A Streptococcal Pharyngitis in Children', 'orgStudyIdInfo': {'id': '13-248'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sofia Strep A FIA', 'type': 'DIAGNOSTIC_TEST', 'description': '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.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Laurence Lacroix, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'Quidel Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Pediatric Emergency Physician', 'investigatorFullName': 'Laurence Lacroix', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}