Penicillin Allergy Testing in STD Clinics

Study Overview
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Brief Summary
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Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing

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

Official Title
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Validate an Easy to Administer Algorithm to Define Penicillin (PCN-B-lactam) Allergy Status in Sexually Transmitted Disease (STD) Clinic Outpatients

Conditions
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Penicillin Allergy

Intervention / Treatment
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* Drug: Penicillin Major Determinant (PrePen) Skin Testing
* Drug: Direct Oral challenge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior history of PCN allergy Exclusion Criteria: No immunodeficiency or contraindication to skin testing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Skin Testing Arm<br>These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge | Drug: Penicillin Major Determinant (PrePen) Skin Testing<br>* Skin testing followed by oral challenge with amoxicillin 250 mg single dose<br>* Other names: Penicillin G Minor Determinant Skin Testing;Drug: Direct Oral challenge<br>* Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose<br>|
| Active Comparator: Direct Oral Challenge<br>These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin | Drug: Direct Oral challenge<br>* Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study | 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 | Baseline | 
| 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 | 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 | 30 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire | 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. | Immediately after intervention | 
| Provider Assessment of Feasibility of Allergy Evaluation at the End of Study | 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. | 18 months |