Penicillin Allergy Testing in STD Clinics

NCT04620746 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB00220384HHSN272201300012I/HHSN27200015
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Penicillin Allergy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire

  Immediately after intervention

• Provider Assessment of Feasibility of Allergy Evaluation at the End of Study

  18 months

Study Arms (2)

Skin Testing Arm

ACTIVE COMPARATOR

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; Drug: Direct Oral challenge

Direct Oral Challenge

ACTIVE COMPARATOR

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

Interventions

Penicillin Major Determinant (PrePen) Skin Testing DRUG

Skin testing followed by oral challenge with amoxicillin 250 mg single dose

Also known as: Penicillin G Minor Determinant Skin Testing

Skin Testing Arm

Direct Oral challenge DRUG

Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose

Direct Oral Challenge; Skin Testing Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior history of PCN allergy

You may not qualify if:

• No immunodeficiency or contraindication to skin testing

Sponsors & Collaborators

• Johns Hopkins University: lead
• Indiana University School of Medicine: collaborator
• Wake Forest University Health Sciences: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• University of Washington: collaborator

Study Sites (2)

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

University of Washington-Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Lillis RA, Barbee LA, McNeil CJ, Newman L, Fortenberry JD, Alvarez-Arango S, Zenilman JM. Randomized Multicenter Trial for the Validation of an Easy-to-Administer Algorithm to Define Penicillin Allergy Status in Sexually Transmitted Infection Clinic Outpatients. Clin Infect Dis. 2024 May 15;78(5):1131-1139. doi: 10.1093/cid/ciae064.

  PMID: 38325290 DERIVED

MeSH Terms

Interventions

Skin Tests

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Results Point of Contact

• Title: Jonathan Zenilman
• Organization: Johns Hopkins University School of Medicine

jzenilm1@jh.edu

410-550-9080

Study Officials

• Jonathan M Zenilman

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: June 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be uploaded and provided when study is completed and analyzed. Completed May 2023

Locations

US (2)