Penicillin Allergy Testing in STD Clinics

Johns Hopkins University

Status and phase: Completed; Phase 4

Conditions: Penicillin Allergy

Treatments: Drug: Direct Oral challenge; Drug: Penicillin Major Determinant (PrePen) Skin Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT04620746

IRB00220384

HHSN272201300012I/HHSN27200015 (Other Grant/Funding Number)

Details and patient eligibility

About

Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing

Full description

all subjects receive risk questionnaire For subjects without high risk responses, randomized to direct oral challenge or PCN skin testing followed by oral challenge

Enrollment: 284 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Prior history of PCN allergy

Exclusion criteria

• No immunodeficiency or contraindication to skin testing

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

Skin Testing Arm

Active Comparator group

Description:

These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge

Treatment:

Drug: Penicillin Major Determinant (PrePen) Skin Testing

Drug: Direct Oral challenge

Direct Oral Challenge

Active Comparator group

Description:

These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin

Treatment:

Drug: Direct Oral challenge