Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2026-02-20 @ 10:11 PM
Study NCT ID:
NCT06528106
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-30
First Post:
2024-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-25', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients admitted to adult medical, surgical and critical care specialities with a penicillin allergy record, where the allergy record is preventing first line antibiotic therapy, that are safely de-labelled.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Penicillin Allergy']}, 'descriptionModule': {'briefSummary': 'To test the implementation of penicillin allergy de-labelling delivered by the responsible clinical teams and the antimicrobial stewardship teams across all medical, surgical and critical care specialities in a UK hospital using the developed toolkit and a validated penicillin allergy decision support tool.', 'detailedDescription': 'Aim:\n\nTo test implementation of the penicillin allergy de-labelling complex intervention in surgical, medical and critical care patient pathway.\n\nObjectives:\n\n* To use the Institute for Health Improvement (IHI) Model for Improvement methodology to implement the penicillin allergy de-labelling complex intervention in each setting (surgery, medicine, critical care)\n* To measure the number of patients meeting inclusion criteria (\\>16 with a penA not prescribed first line antibiotics) who have had their penicillin allergy record assessed by the wider clinical teams and separately by the AMS team.\n* To measure the patient uptake of penicillin allergy record removal (i.e. the rate of patient declining de-label / DOC).\n\nTo interview 10-15 patients and 10-15 healthcare workers to gain insight into the penicillin allergy de labelling process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult (\\>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll adult (\\>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT06528106', 'acronym': 'REPeAL', 'briefTitle': 'Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL)', 'organization': {'class': 'OTHER', 'fullName': 'Royal Cornwall Hospitals Trust'}, 'officialTitle': 'Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL)', 'orgStudyIdInfo': {'id': '2324.RCHT.66'}, 'secondaryIdInfos': [{'id': '335337', 'type': 'OTHER', 'domain': 'IRAS'}, {'id': 'NIHR300542', 'type': 'OTHER_GRANT', 'domain': 'NIHR'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TR1 3LJ', 'city': 'Truro', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Cornwall Hospitals Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}