Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT05090527
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2021-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Penicillin Allergy Delabeling Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None, open provocation test with amoxicillin for eligible patients after risk stratification with a questionnaire.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Entry criteria: Penicillin allergy noted in patients journal or patient reported.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2021-10-21', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validating of a risk stratification tool ( in Norwegian) and advanced drug provocation challenge', 'timeFrame': '24 months', 'description': 'Negative predictive value of the risk stratification tool'}], 'secondaryOutcomes': [{'measure': 'Number of patients with treatment related adverse events on oral provocation testing.', 'timeFrame': '24 months', 'description': 'number of patients with treatment related adverse event on oral provocation testing.'}, {'measure': 'Number of patients correctly delabeled', 'timeFrame': '24 months', 'description': 'Og the patientents included in the implementation in clinical practice, how many had a correct procedure and result.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['penicillin allergy', 'clinical pathway', 'implementation', 'delabeling'], 'conditions': ['Penicillin Allergy']}, 'referencesModule': {'references': [{'pmid': '37868111', 'type': 'RESULT', 'citation': 'Alnaes MB, Oppegaard O, Kittang BR, Lygre SHL, Langeland AB, Skodvin B, Bjanes T, Storaas T. A new pathway for penicillin delabeling in Norway. World Allergy Organ J. 2023 Oct 16;16(11):100829. doi: 10.1016/j.waojou.2023.100829. eCollection 2023 Nov.'}]}, 'descriptionModule': {'briefSummary': 'A investigational study to establish:\n\n1. A validated cllinical pathway for delabeling declared Penicillin allergiy outside allergologic departments.\n2. A survey to examine anesthesiologists attitudes and knowledge about penicillin delabeling.\n3. A qualitative focus group study investigating barriers and facilitators in penicillin delabeling among hospital nurses and physichians.\n\n2\\. Implement the pathway for delabeling declared penicillin allergy outside allergologic clinics across the Western Norway health region.', 'detailedDescription': 'Patients labeled penicillin allergic is a significant and growing public health problem. 10% of all patients report penicillin allergy. 9 out of 10 however tolerate penicillin on provocation, To be labeled as penicillin allergic has several well documented negative health outcomes for the individual, and on a public health scale.\n\nOne of the biggest obstacles in delabeling penicillin allergy is the lack of validated tools i Norwegian, the lack of in vitro tests for severe late /T cell mediated reactions and the accessibility of the gold standard procedure, drug provocation test.\n\nIn this study patients having a penicillin allergy label will after giving their written concent be screened used a risk stratification tool. The low risk patient will then directly undergo a single full dose amoxicillin challenge. High risk patients are refered to a allergologic clinic and undergoes full allergologic examination. The investigators seek to document that in low risk patients is a single dose Amoxicillin challenge safe and beneficial outside an allergologic clinic, and to validate the risk stratification tool in Norwegian.\n\nTo implement such pathways i qualitative data is needed to facilitate the right efforts and translate the method into every day clinical practice in a sustainable way. Here a anesthesiologist survey and focus group interviews with hospital nurses and physichians is planned.\n\nFinally we will implement the method in an implementation study across the Western Norway Health region'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Penicillin allergy in the patient journal oder patient reported\n\nExclusion Criteria:\n\n* Not able to give concent. Under 16 years of age.'}, 'identificationModule': {'nctId': 'NCT05090527', 'acronym': 'PenProv', 'briefTitle': 'Penicillin Allergy Delabeling Project', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Penicillin Delabeling With Help of a Risk Stratification Tool, Advanced Provocation Tests in a Non Allergologic Unit', 'orgStudyIdInfo': {'id': '199210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Directly delabeled trough risk stratification tool', 'description': 'Patients who are stratified as " no penicillin allergy" undergo a one dose full dose provocation test with 500 mg amoxicillin.', 'interventionNames': ['Diagnostic Test: Risk stratification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low risk patients', 'description': 'Patients stratified as low risk on penicillin provocation undergo a one dose full dose provocation test with 500mg amoxicillin', 'interventionNames': ['Diagnostic Test: Risk stratification']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High risk', 'description': 'Patient stratified as high risk undergo a full allergologic work up, and only some of these will undergo a provocation test.', 'interventionNames': ['Diagnostic Test: Risk stratification']}], 'interventions': [{'name': 'Risk stratification', 'type': 'DIAGNOSTIC_TEST', 'description': 'advanced penicillin challenge after risk stratification', 'armGroupLabels': ['Directly delabeled trough risk stratification tool', 'High risk', 'Low risk patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Førde', 'country': 'Norway', 'facility': 'Helse Førde', 'geoPoint': {'lat': 61.45217, 'lon': 5.85717}}], 'overallOfficials': [{'name': 'Torgeir Storaas, phd', 'role': 'STUDY_CHAIR', 'affiliation': 'RAAO vest'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Fonna', 'class': 'OTHER'}, {'name': 'Helse Forde', 'class': 'OTHER'}, {'name': 'Haraldsplass Deaconess Hospital', 'class': 'OTHER'}, {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}