Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-28 @ 3:59 PM
Study NCT ID:
NCT05010304
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2021-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Penicillin De-labeling in the Pediatric Primary Care Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'timothy.chow@utsouthwestern.edu', 'phone': '2144569093', 'title': 'Dr Timothy Chow', 'organization': 'University of Texas Southwestern'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 days after amoxicillin challenge completion', 'description': 'Adverse events were captured by study staff during the 60 minute observation period with amoxicillin challenge, and again assessed at 7 days after challenge completion by study staff.', 'eventGroups': [{'id': 'EG000', 'title': 'Pediatric Patients With a History of Penicillin Allergy', 'description': 'Amoxicillin: Two-dose amoxicillin challenge', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 2, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rash', 'notes': 'Cutaneous-only reaction, resolving with oral antihistamines', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjects Who Complete Risk-stratification of Penicillin Allergy in the Pediatric Primary Care Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pediatric Patients With a History of Penicillin Allergy', 'description': 'Amoxicillin: Two-dose amoxicillin challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjects Stratified as Low-risk With a Negative Immediate Amoxicillin Challenge in the Pediatric Primary Care Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pediatric Patients With a History of Penicillin Allergy', 'description': 'Amoxicillin: Two-dose amoxicillin challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pediatric Patients With a History of Penicillin Allergy', 'description': 'Amoxicillin: Two-dose amoxicillin challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10-14 months after amoxicillin challenge', 'description': 'Subjects who have a penicillin allergy label added back to their electronic health record at 10-14 months after amoxicillin challenge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pediatric Patients With a History of Penicillin Allergy', 'description': 'Amoxicillin: Two-dose amoxicillin challenge'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pediatric Patients With a History of Penicillin Allergy', 'description': 'Amoxicillin: Two-dose amoxicillin challenge'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '0.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-29', 'size': 459631, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-23T10:00', 'hasProtocol': True}, {'date': '2021-10-06', 'size': 2037953, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-23T10:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2021-08-10', 'resultsFirstSubmitDate': '2024-07-23', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-23', 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjects Who Complete Risk-stratification of Penicillin Allergy in the Pediatric Primary Care Setting', 'timeFrame': 'Day 1'}, {'measure': 'Subjects Stratified as Low-risk With a Negative Immediate Amoxicillin Challenge in the Pediatric Primary Care Setting', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge', 'timeFrame': '10-14 months after amoxicillin challenge', 'description': 'Subjects who have a penicillin allergy label added back to their electronic health record at 10-14 months after amoxicillin challenge.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['penicillin', 'allergy'], 'conditions': ['Penicillin Allergy', 'Penicillin Reaction']}, 'referencesModule': {'references': [{'pmid': '36738783', 'type': 'DERIVED', 'citation': 'Chow TG, Patel G, Mohammed M, Johnson D, Khan DA. Delabeling penicillin allergy in a pediatric primary care clinic. Ann Allergy Asthma Immunol. 2023 May;130(5):667-669. doi: 10.1016/j.anai.2023.01.034. Epub 2023 Feb 2. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'While reported adverse reactions to penicillins are common, most patients with a penicillin allergy label can safely tolerate penicillins, and elective evaluation for penicillin allergy has been recommended. For low-risk patients, direct oral challenge may be an optimal approach as a delabeling strategy. However, there is a vast disparity between the number of patients with a penicillin allergy label and practicing allergists in the United States, and implementing outpatient primary care-based delabeling strategies in low-risk patients may increase access to delabeling assessments. However, a recent survey of pediatricians identified perceived barriers to implementing penicillin allergy evaluations into their routine care. Significant gaps in knowledge exist regarding the feasibility of this approach involving risk stratification evaluation of reported penicillin adverse reactions and direct amoxicillin challenge procedures in low-risk patients in the pediatric primary care setting. With this, the primary aim of this study is to evaluate the number of patients for which risk-stratification and direct amoxicillin challenge are successfully completed in an outpatient pediatric primary care clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children from ages 2-18 years with a history of parent-reported penicillin allergy.\n\nExclusion Criteria:\n\n* Children with a history of reaction consistent with a severe cutaneous adverse reaction to penicillin as defined as a history of oral blisters, diffuse skin peeling or blisters after taking a penicillin, or having the diagnosis of Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, Drug rash with eosinophilia and systemic symptoms will be excluded. Pregnant and breastfeeding female subjects will be excluded'}, 'identificationModule': {'nctId': 'NCT05010304', 'briefTitle': 'Penicillin De-labeling in the Pediatric Primary Care Setting', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Penicillin De-labeling in the Pediatric Primary Care Setting', 'orgStudyIdInfo': {'id': 'STU-2021-0517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pediatric Patients with a history of penicillin allergy', 'interventionNames': ['Drug: Amoxicillin']}], 'interventions': [{'name': 'Amoxicillin', 'type': 'DRUG', 'description': 'Two-dose amoxicillin challenge', 'armGroupLabels': ['Pediatric Patients with a history of penicillin allergy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American College of Allergy, Asthma and Immunology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Timothy Chow, MD', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}