Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-02 @ 1:23 PM
Study NCT ID:
NCT07127835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Provocation After Nurse-Directed Assessment (PANDA) Study
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-08-10', 'studyFirstSubmitQcDate': '2025-08-10', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delabelling Success Rate', 'timeFrame': '6 months', 'description': 'Assess the proportion of low-risk patients who are no longer considered allergic to penicillin after delabeling.'}], 'secondaryOutcomes': [{'measure': 'Health-Related Quality of Life', 'timeFrame': '6 months', 'description': "Measure changes in patients' quality of life before and after delabeling using the validated Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q). The DrHy-Q is a 15-item instrument answered on a 5-point Likert scale, with scores ranging from 15 (no QoL impairment) to 225 (worst QoL impairment)."}, {'measure': 'Antibiotic Usage Rate', 'timeFrame': '6 months', 'description': 'Evaluate changes in the usage rates of penicillin and alternative antibiotics after delabeling.'}, {'measure': 'Age Group Analysis', 'timeFrame': '6 months', 'description': 'Compare delabeling success rates across different age groups (e.g., 18-30 years, 31-50 years, and 51 years and older).'}, {'measure': 'Immunocompetence Status', 'timeFrame': '6 months', 'description': 'Analyze differences in delabeling success rates and safety between immunocompetent and immunocompromised patients.'}, {'measure': 'Initial vs. Recurrent Labeling', 'timeFrame': '6 months', 'description': 'Compare delabeling success rates between patients with an initial penicillin allergy label and those with recurrent labels.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nurse-led Service', 'Drug Provocation Test', 'Delabelling'], 'conditions': ['Drug Allergy', 'Penicillin Allergy']}, 'referencesModule': {'references': [{'pmid': '19252115', 'type': 'BACKGROUND', 'citation': 'Schnyder B, Pichler WJ. Mechanisms of drug-induced allergy. Mayo Clin Proc. 2009 Mar;84(3):268-72. doi: 10.4065/84.3.268.'}, {'pmid': '29712672', 'type': 'BACKGROUND', 'citation': 'Abrams EM, Khan DA. Diagnosing and managing drug allergy. CMAJ. 2018 Apr 30;190(17):E532-E538. doi: 10.1503/cmaj.171315. No abstract available.'}, {'pmid': '9002492', 'type': 'BACKGROUND', 'citation': 'Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1997 Jan 22-29;277(4):301-6.'}, {'pmid': '19075990', 'type': 'BACKGROUND', 'citation': 'Pourpak Z, Fazlollahi MR, Fattahi F. Understanding adverse drug reactions and drug allergies: principles, diagnosis and treatment aspects. Recent Pat Inflamm Allergy Drug Discov. 2008 Jan;2(1):24-46. doi: 10.2174/187221308783399289.'}, {'pmid': '29313907', 'type': 'BACKGROUND', 'citation': 'Patton K, Borshoff DC. Adverse drug reactions. Anaesthesia. 2018 Jan;73 Suppl 1:76-84. doi: 10.1111/anae.14143.'}]}, 'descriptionModule': {'briefSummary': "The study aims to evaluate the effectiveness and safety of a collaborative nurse-allergist approach in penicillin allergy delabeling services. It also seeks to assess the impact on patients' quality of life and compare resource utilization and cost-effectiveness between the nurse-allergist collaborative approach and the traditional allergist-led approach.", 'detailedDescription': "This study hypothesizes that by involving both nurses and allergists in the delabeling process and categorizing patients based on risk levels, it will achieve comparable success rates, safety, and improvements in patients' quality of life. This approach is expected to offer superior advantages in terms of time efficiency, resource utilization, and cost-effectiveness compared to traditional allergist-led services."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated at a participating hospital who have a documented penicillin allergy label, are evaluated for penicillin allergy through either the nurse-allergist or allergist-led approach, and have available demographic and clinical data.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving inpatient or outpatient treatment at a participating hospital during the study period;\n* Possessing a documented penicillin allergy label;\n* Underwent penicillin allergy evaluation by the nurse-allergist collaborative approach or the traditional allergist-led approach\n* Demographic and clinical data required for the study available.\n\nExclusion Criteria:\n\n* Patients unable to provide a complete medication history or history of penicillin allergy;\n* Patients with only emergency or short-term treatment records;\n* Patients who have taken steroids, antihistamines, or similar medications within the last 3 days.'}, 'identificationModule': {'nctId': 'NCT07127835', 'acronym': 'PANDAS', 'briefTitle': 'Provocation After Nurse-Directed Assessment (PANDA) Study', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Provocation After Nurse-Directed Assessment (PANDA) Study', 'orgStudyIdInfo': {'id': 'PANDAstudy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nurse-led group', 'description': 'Receive Nurse-led penicillin allergy delabelling service', 'interventionNames': ['Diagnostic Test: Nurse-led penicillin allergy delabelling service']}, {'label': 'Allergist-led group', 'description': 'Receive Allergist-led penicillin allergy delabelling service', 'interventionNames': ['Diagnostic Test: Allergist-led penicillin allergy delabelling service']}], 'interventions': [{'name': 'Nurse-led penicillin allergy delabelling service', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients in this group undergo risk assessment and categorization by nurses to identify low-risk individuals for delabeling. For these patients, nurses will collaborate with allergists in the delabeling process.', 'armGroupLabels': ['Nurse-led group']}, {'name': 'Allergist-led penicillin allergy delabelling service', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients assigned to this group will undergo risk assessment and delabeling led by allergists for both low-risk and high-risk cases.', 'armGroupLabels': ['Allergist-led group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '999077', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '999077', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '999077', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '999077', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Elaine Lee', 'role': 'CONTACT', 'email': 'le446@hku.hk', 'phone': '852 9440 3349'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Prof. Sophia Siu-chee Chan', 'investigatorAffiliation': 'The University of Hong Kong'}}}}