Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-04 @ 6:22 PM
Study NCT ID:
NCT03499457
Status:
UNKNOWN
Last Update Posted:
2018-04-17
First Post:
2018-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Penicillin Allergy in Shfayim Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-08', 'studyFirstSubmitDate': '2018-04-08', 'studyFirstSubmitQcDate': '2018-04-08', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'immidiate urticarial reaction', 'timeFrame': 'with 2 hours of test', 'description': 'shortness of breath, angioedema'}], 'secondaryOutcomes': [{'measure': 'rash', 'timeFrame': 'with 2 hours of test', 'description': 'body rash or itch seen by patient or physician'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Penicillin Allergy', 'chalenge test', 'primary clinic'], 'conditions': ['Penicillin Allergy']}, 'descriptionModule': {'briefSummary': 'revising penicillin allergy in the medical records, by taking full medical history and giving a challange test, in order to imrove the medical records and treatment possibilities.', 'detailedDescription': 'issuing a list of patients with a title of penicillin allergy in their medical record. inviting these patients to an appointmnet with their family physician, in which a specific history will be take to evaluate the quality of the allergy.\n\npatients with suscpition of a life threatening allergic reaction will be reffered to an allergy clinic for the challange test. the rest of the pateints will be given the test in the primary clinic: 1ml (50 grams) of amoxicillin, and an hour later a full dose of 500 mg amoxicillin.\n\nafter determining no allergic reaction develops the title will be erased from the medical record.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\npenicillin allergy in the medical record\n\nExclusion Criteria:\n\npregnancy lack of informed consent'}, 'identificationModule': {'nctId': 'NCT03499457', 'briefTitle': 'Penicillin Allergy in Shfayim Clinic', 'organization': {'class': 'OTHER', 'fullName': 'Clalit Health Services'}, 'officialTitle': 'Penicillin Allergy in Shfayim Clinic', 'orgStudyIdInfo': {'id': '0185-17-COM2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment', 'description': 'penicillin chalange test, as descibed.', 'interventionNames': ['Drug: Amoxicillin']}], 'interventions': [{'name': 'Amoxicillin', 'type': 'DRUG', 'description': 'chalange test of 50 mg, and after an hour 500 mg', 'armGroupLabels': ['treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'lital f goldberg, MD. MPH.', 'role': 'CONTACT', 'email': 'litalmargalith@gmail.com', 'phone': '972544248284'}], 'overallOfficials': [{'name': 'lital f goldberg, MD. MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clalit Health Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clalit Health Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dr lital goldberg', 'investigatorFullName': 'Dr. Lital Goldberg', 'investigatorAffiliation': 'Clalit Health Services'}}}}