Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-08 @ 4:11 AM
Study NCT ID:
NCT00535093
Status:
COMPLETED
Last Update Posted:
2010-05-04
First Post:
2007-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}], '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'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-02', 'studyFirstSubmitDate': '2007-09-24', 'studyFirstSubmitQcDate': '2007-09-25', 'lastUpdatePostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity of RST specificity of RST', 'timeFrame': '3-4 months'}], 'secondaryOutcomes': [{'measure': 'ease of use effect on antibacterial prescribing', 'timeFrame': '3-4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharyngitis', 'Community infections', 'Rapid Testing', 'Group A Streptococcus'], 'conditions': ['Pharyngitis', 'Streptococcus Pyogenes Infection', 'Streptococcus Pyogenes Identification']}, 'referencesModule': {'references': [{'pmid': '16567603', 'type': 'BACKGROUND', 'citation': 'Humair JP, Revaz SA, Bovier P, Stalder H. Management of acute pharyngitis in adults: reliability of rapid streptococcal tests and clinical findings. Arch Intern Med. 2006 Mar 27;166(6):640-4. doi: 10.1001/archinte.166.6.640.'}, {'pmid': '12394813', 'type': 'BACKGROUND', 'citation': 'Gieseker KE, Mackenzie T, Roe MH, Todd JK. Comparison of two rapid Streptococcus pyogenes diagnostic tests with a rigorous culture standard. Pediatr Infect Dis J. 2002 Oct;21(10):922-7. doi: 10.1097/00006454-200210000-00007.'}, {'pmid': '15069046', 'type': 'BACKGROUND', 'citation': 'McIsaac WJ, Kellner JD, Aufricht P, Vanjaka A, Low DE. Empirical validation of guidelines for the management of pharyngitis in children and adults. JAMA. 2004 Apr 7;291(13):1587-95. doi: 10.1001/jama.291.13.1587.'}, {'pmid': '12087516', 'type': 'BACKGROUND', 'citation': 'Bisno AL, Gerber MA, Gwaltney JM Jr, Kaplan EL, Schwartz RH; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of group A streptococcal pharyngitis. Infectious Diseases Society of America. Clin Infect Dis. 2002 Jul 15;35(2):113-25. doi: 10.1086/340949. No abstract available.'}, {'pmid': '16832002', 'type': 'BACKGROUND', 'citation': 'Linder JA, Chan JC, Bates DW. Evaluation and treatment of pharyngitis in primary care practice: the difference between guidelines is largely academic. Arch Intern Med. 2006 Jul 10;166(13):1374-9. doi: 10.1001/archinte.166.13.1374.'}, {'pmid': '11147989', 'type': 'BACKGROUND', 'citation': 'Ebell MH, Smith MA, Barry HC, Ives K, Carey M. The rational clinical examination. Does this patient have strep throat? JAMA. 2000 Dec 13;284(22):2912-8. doi: 10.1001/jama.284.22.2912.'}, {'pmid': '16278359', 'type': 'BACKGROUND', 'citation': 'Linder JA, Bates DW, Lee GM, Finkelstein JA. Antibiotic treatment of children with sore throat. JAMA. 2005 Nov 9;294(18):2315-22. doi: 10.1001/jama.294.18.2315.'}]}, 'descriptionModule': {'briefSummary': 'There is a large over-use of antibiotics in family medicine, especially in upper respiratory tract infections.\n\nThis study is designed to determine if the use of rapid Streptococcal tests in primary care clinics can lower the rate of antibiotic use while not missing bacterial infections.', 'detailedDescription': 'Pharyngitis is a clinical diagnosis which requires antibiotic treatment only if caused by group A Streptococcus (GAS).\n\nHowever, it is impossible to identify by clinical signs alone those patients whose symptoms are caused by this pathogen.\n\nDiagnosis demands a throat culture, which requires at least 24 hours to rule in infection and 48 hours to rule it out.\n\nRapid Streptococcal tests (RST) based on antigen identification have been in use for over 10 years. These allow determination of the presence of GAS within 10 minutes using tests designed for point of care use.\n\nWhile the specificity of these tests is generally reported as high (90-95%), the sensitivity is quoted at between 60% and 90% , depending on author affiliation, place of testing and type of test.\n\nVarious protocols have been put forward, these combine clinical signs (Centor criteria) with RST or throat cultures in order to lower antibiotic over-use.\n\nThese protocols are often under-used by primary physicians, even when RSTs are available.\n\nClalit health services, the largest HMO in Israel, has decided to evaluate all the RSTs available in the country in community clinic settings in order to determine the feasibility of adopting these tests to improve clinical care.\n\nThe sensitivity, specificity and ease-of-use will be assessed in 25 clinics in various settings (urban and rural). Gold standard will be a standard throat culture processed in the district laboratory.\n\nThe effect of point-of-care testing will be estimated by requiring physicians to decide on antibiotic use before receiving the result of the RST. (They will be free to change this decision after the test).\n\nClinics were selected by number of throat cultures sent in previous years. The number of patients was determined using the positivity rates of 2005. The results of this study will enable us to estimate the benefit and cost of adopting RSTs, and to determine in which situations they will be most efficacious.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sore throat\n* at least two Centor criteria:\n* fever \\> 38 deg C or history of fever\n* enlarged cervical lymph nodes\n* tonsillar exudate\n* lack of cough\n* age 3-14 years\n\nExclusion Criteria:\n\n* antibiotic treatment in preceding 7 days\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT00535093', 'briefTitle': 'An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'A Comparison of Available Rapid Streptococcus A Tests in Community Clinics in Israel: Accuracy, Ease of Use and Acceptability.', 'orgStudyIdInfo': {'id': 'HT4152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'All patients fulfilling inclusion criteria will be evaluated for GAS infection using both a rapid streptococcus test and also a standard throat culture', 'interventionNames': ['Device: rapid streptococcal testing']}], 'interventions': [{'name': 'rapid streptococcal testing', 'type': 'DEVICE', 'description': 'Each patient will have both RST and standard throat culture performed. Final diagnosis and treatment will be determined by throat culture', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Clalit Health Services', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Ian N Miskin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clalit Health Services, Jerusalem district'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dept of Family Medicine, Faculty of Medicine, Hebrew University, Jerusalem, Israel', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ian MiskinMD', 'oldOrganization': 'Clalit Health Services Jerusalem Israel'}}}}