Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT03581604
Status:
RECRUITING
Last Update Posted:
2023-11-03
First Post:
2018-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
De-labeling of Patients With False Diagnosis of Penicillin Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004342', 'term': 'Drug Hypersensitivity'}], 'ancestors': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patient group consisting of patients labeled as penicillin allergic.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-01', 'studyFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Penicillin allergy in the studied group', 'timeFrame': 'up to 4 years', 'description': 'Frequency of true penicillin allergy in the study group'}, {'measure': 'Negative predictive value of the allergy work- up', 'timeFrame': '3 weeks', 'description': 'If the allergy work-up is negative, drug provocation test with penicillin will be performed. The purpose of the drug challenge is to confirm lack of allergy and confirm the negative predictive value of the allergy work-up.'}], 'secondaryOutcomes': [{'measure': 'Use of b-lactams after negative allergy work-up and development of new drug reactions following negative testing.', 'timeFrame': '12 months', 'description': 'Patients going through an allergy workup with negative results, will be retrospectively contacted within one year after investigation. Telephone interview where the following questions will be asked:1) "Have you received antibiotic therapy since being seen in the allergy clinic?" 2) "If you have been treated, what drug did you take?" 3) "As a result of this, did you have a reaction to the antibiotics?" "If yes, what kind of reaction have you developed?" 4) "If you didn\'t take the drug you were challenged with what was the reason for that?"'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Penicillin/b-lactams'], 'conditions': ['Allergy Drug']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the prevalence of penicillin allergy, evaluate the diagnostic value of the allergologic work-up used in the study, and the health effects of penicillin allergy.', 'detailedDescription': 'Penicillin allergy is the most common of self-reported drug allergies and un-verified penicillin allergy is a significant and growing public health problem. 10% of all patients report penicillin allergy. However, there is large discrepancy between reported penicillin allergy and true allergy. Despite its high prevalence, greater than 90% of such patients are in fact able to tolerate the medication without allergic reactions.\n\nIn this study patients having a penicillin allergy label will be investigated to confirm or to exclude the allergy diagnosis. The diagnostic value of the allergen test panel and the allergologic work-up will be evaluated. Clinical parameters as well as immunological will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who are referred to the department of Pulmonary medicine with clinical history suspected of having penicillin allergy.\n* The control group will be healthy adult volunteers with no history of any personal or family history of drug allergy, atopy, inflammatory or autoimmune diseases.\n\nExclusion Criteria:\n\n* Systemic reactions such as DRESS, any internal organ involvement\n* Clinical history of Type II-III hypersensitivity reaction\n* Severe Type IV hypersensitivity reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, vasculitis, acute generalized exanthematous pustulosis\n* Chronic idiopathic urticaria on antihistamine maintenance treatment/anti-IgE treatment\n* Medication which can affect the test outcome\n* Active signs of an underlying disease such as uncontrolled asthma\n* Cardiac disease with increased risk of serious anaphylaxis\n* Pregnancy/Breastfeeding\n* Reaction within the last 4-6 weeks'}, 'identificationModule': {'nctId': 'NCT03581604', 'briefTitle': 'De-labeling of Patients With False Diagnosis of Penicillin Allergy', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Diagnostic De-labeling of Patients With False Diagnosis of Penicillin Allergy: A Tool for Improving Antimicrobial Treatment and Reducing Antimicrobial Resistance', 'orgStudyIdInfo': {'id': '2017/2119/REK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients labeled as penicillin allergic', 'description': 'Patients labeled as penicillin allergic will be allergologically investigated to confirm/exclude the diagnosis. Allergy work-up will be performed. Blood samples will be obtained.Questionnaire to evaluate the effectiveness of the intervention.', 'interventionNames': ['Diagnostic Test: Allergy work-up', 'Other: Blood samples']}], 'interventions': [{'name': 'Allergy work-up', 'type': 'DIAGNOSTIC_TEST', 'description': 'Allergy work-up', 'armGroupLabels': ['Patients labeled as penicillin allergic']}, {'name': 'Blood samples', 'type': 'OTHER', 'description': 'Blood samples', 'armGroupLabels': ['Patients labeled as penicillin allergic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'state': 'Postbox 4950 Nydalen', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Eva Stylianou, PHD', 'role': 'CONTACT', 'email': 'eva.stylianou@ous-hf.no', 'phone': '004722118784'}], 'facility': 'Oslo University Hospital, Dpt of Pulmonary Diseases, Ullevål', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Eva Stylianou, Phd', 'role': 'CONTACT', 'email': 'eva.stylianou@ous-hf.no', 'phone': '004722118784'}], 'overallOfficials': [{'name': 'Eva Stylianou, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eva Stylianou', 'investigatorAffiliation': 'Oslo University Hospital'}}}}