Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
284 participants
INTERVENTIONAL
2021-06-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Skin Testing Arm
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
Penicillin Major Determinant (PrePen) Skin Testing
Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct Oral challenge
Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Direct Oral Challenge
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
Direct Oral challenge
Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Interventions
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Penicillin Major Determinant (PrePen) Skin Testing
Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct Oral challenge
Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Indiana University School of Medicine
OTHER
Wake Forest University Health Sciences
OTHER
Louisiana State University Health Sciences Center in New Orleans
OTHER
University of Washington
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Jonathan M Zenilman
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Louisiana State University
New Orleans, Louisiana, United States
University of Washington-Harborview Medical Center
Seattle, Washington, United States
Countries
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References
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Lillis RA, Barbee LA, McNeil CJ, Newman L, Fortenberry JD, Alvarez-Arango S, Zenilman JM. Randomized Multicenter Trial for the Validation of an Easy-to-Administer Algorithm to Define Penicillin Allergy Status in Sexually Transmitted Infection Clinic Outpatients. Clin Infect Dis. 2024 May 15;78(5):1131-1139. doi: 10.1093/cid/ciae064.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HHSN272201300012I/HHSN27200015
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB00220384
Identifier Type: -
Identifier Source: org_study_id
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