Penicillin Allergy Testing in STD Clinics

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

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

Study Overview

• Status: Completed
• Conditions: Penicillin Allergy
• Intervention / Treatment: Drug: Penicillin Major Determinant (PrePen) Skin Testing; Drug: Direct Oral challenge

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 Type: Interventional
• Enrollment (Actual): 284
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington-Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Prior history of PCN allergy

Exclusion Criteria:

• No immunodeficiency or contraindication to skin testing

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Skin Testing Arm; 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; Skin testing followed by oral challenge with amoxicillin 250 mg single dose; Other Names: Penicillin G Minor Determinant Skin Testing; Drug: Direct Oral challenge; Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Active Comparator: Direct Oral Challenge; 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; Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Wake Forest University Health Sciences; University of Washington; Louisiana State University Health Sciences Center in New Orleans; Indiana University School of Medicine
• Investigators: Principal Investigator: Jonathan M Zenilman, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity; Anti-Infective Agents; Anti-Bacterial Agents; Penicillins; Penicillin G
• Other Study ID Numbers: IRB00220384; HHSN272201300012I/HHSN27200015 (Other Grant/Funding Number: National Institute Of Allergy & Infectious Disease)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Blinded data set is available
• IPD Sharing Time Frame: Data will be uploaded and provided when study is completed and analyzed. Completed May 2023
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No