Penicillin Allergy Testing in STD Clinics

Phase 4

Completed

• Conditions: Penicillin Allergy
• Interventions: Drug: Direct Oral challenge; Drug: Penicillin Major Determinant (PrePen) Skin Testing

• Registration Number: NCT04620746
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-09
• Study Start: 2021-06-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Results First Submitted: 2023-06-02
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-20
• Last Update Submitted: 2023-09-20
• Results First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

• Prior history of PCN allergy

Exclusion Criteria

• No immunodeficiency or contraindication to skin testing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Oral Challenge	Direct Oral challenge	These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
Skin Testing Arm	Penicillin Major Determinant (PrePen) Skin Testing	These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
Skin Testing Arm	Direct Oral challenge	These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge

Primary Outcome Measures

Name	Time	Method
Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study	Baseline	Used yes/no questionnaire designed by study team. Any positive response on the high-risk history was grounds for exclusion from randomization to allergy testing arm
Safety of Direct Oral Challenge Defined by Number of Subjects Who Did Not Have Pre-defined Changes in Vital Signs or Pre-defined Emergence of New Respiratory or Skin Symptoms After Oral Challenge	30 minutes after intervention	Safety was determined by the presence or absence of adverse reactions. Symptoms assessed included pruritis, flushing, shortness of breath. Physical examination included vital signs, blood pressure, pulse, respiratory rate and peak expiratory flow

Secondary Outcome Measures

Name	Time	Method
Provider Assessment of Feasibility of Allergy Evaluation at the End of Study	18 months	Provider assessment of feasibility of providing PCN testing in the STD clinic setting. This was based on a team-developed questionnaire using Likert scale questions that asked about feasibility and self-efficacy in performing the assessments. Feasibility defined by 1-5 scale, with 1= highly feasible and 5=not feasible. Reported as number of providers who found PCN testing feasible.
Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire	Immediately after intervention	Brief Acceptabilty Questionnaire to subjects on acceptability of PCN allergy testing in the STD clinic setting. Reported as number of participants who found testing acceptable. Questionnaire asked subjects whether they found the process helpful and whether they would return for this type of testing. Using a 1-5 scale, with 1 defined as extremely helpful and 5 defined as not helpful.

Trial Locations

Locations (2)

University of Washington-Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Louisiana State University; 🇺🇸 New Orleans, Louisiana, United States