Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT06414694
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-16
First Post:
2024-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inpatient Penicillin Delabeling for Low-Risk Patients
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Direct Oral Challenge', 'timeFrame': '2 hours', 'description': 'Pass or Failure of direct oral challenge'}], 'secondaryOutcomes': [{'measure': 'Follow-up at 48', 'timeFrame': '48 hours', 'description': 'Follow-up phone call to assess adverse reaction by 48 hours. Data to be collected by screening questionnaire to assess for reactions such as fever, rash, manufacturer labeled adverse side effects.'}, {'measure': 'Follow-up at 6 months', 'timeFrame': '6 months', 'description': 'Follow-up phone call to assess subsequent tolerance or reaction of penicillin based antibiotic if prescribed in this time period. Data to be collected by screening questionnaire.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Penicillin', 'Drug Allergy']}, 'descriptionModule': {'briefSummary': "This study seeks to enroll patients admitted to a children's hospital with identified penicillin allergy. A screening checklist is performed to identify patients with very low or low risk histories of penicillin allergy to offer direct oral challenges to the antibiotic class to de-label patient's with drug allergies.", 'detailedDescription': "This is a pilot study looking to utilize a novel criterion to identify low risk penicillin allergies for patients admitted to a children's hospital to evaluate safety and efficacy of direct oral challenges to patients with very low or low risk histories as identified in novel criterion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>2 years\n* Patients identified via EMR as having a penicillin, amoxicillin, amoxicillin/clavulanic acid allergy\n\nExclusion Criteria:\n\n* Female patients aged \\>8 years of age\n* Patients with hemodynamic instability\n* Patients identified with moderate or high risk histories per protocol\n* Patients currently taking oral antihistamines in 48 hours prior to direct challenge\n* Patients currently taking oral steroids in 48 hours prior to direct challenge\n* Patients currently receiving medications for nausea, shortness of breath,'}, 'identificationModule': {'nctId': 'NCT06414694', 'briefTitle': 'Inpatient Penicillin Delabeling for Low-Risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Inpatient Penicillin Delabeling for Low-Risk Patients', 'orgStudyIdInfo': {'id': '23-09373-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Direct Challenge', 'description': 'Patients who met enrollment criteria proceed to direct oral challenge with penicillin with one hour observation, 48 hour phone call, six month follow-up.', 'interventionNames': ['Procedure: Direct Oral Challenge']}], 'interventions': [{'name': 'Direct Oral Challenge', 'type': 'PROCEDURE', 'description': 'Direct oral challenge to penicillin at a goal dose of 45 mg/kg given in a 10%/90% dose', 'armGroupLabels': ['Direct Challenge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}