Penicillin Allergy Testing in STD Clinics

Penicillin Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04620746
• Other study ID #: IRB00220384
• Secondary ID: HHSN272201300012
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prior history of PCN allergy

Exclusion Criteria:

• No immunodeficiency or contraindication to skin testing

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Hypersensitivity
• Penicillin Allergy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Louisiana State University	New Orleans	Louisiana
United States	University of Washington-Harborview Medical Center	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins University	Indiana University School of Medicine, Louisiana State University Health Sciences Center in New Orleans, University of Washington, Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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