Penicillin Allergy Testing in STD Clinics

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04620746

Collaborator

Indiana University School of Medicine (Other), Wake Forest University Health Sciences (Other), Louisiana State University Health Sciences Center in New Orleans (Other), University of Washington (Other)

1,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

500

Patients Per Site

26.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Penicillin Allergy	Drug: Penicillin Major Determinant (PrePen) Skin Testing Drug: Direct Oral challenge	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Sensitivity in predicting true allergy as assessed by a questionnaire [Immediately after intervention]
PCN allergy questionnaire developed in consultation with experts and will be scored.
Safety of direct oral challenge as assessed by a composite score to be designed [Immediately after intervention]
In subjects with low PCN allergy risk, direct oral challenge will be evaluated for safety using a composite score from a number of assessments to be designed.

Secondary Outcome Measures

Patient Acceptability of PCN Testing/Oral Challenge as assessed by a questionnaire [Immediately after intervention]
Brief Questionnaire to subjects on acceptability of PCN allergy testing in the STD clinic setting.
Change in provider assessment of feasibility of PCN Testing/Oral Challenge as assessed by a questionnaire [Baseline and at the end of study, up to 18 months]
Provider assessment of feasibility of providing PCN testing in the STD clinic setting.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Prior history of PCN allergy

Exclusion Criteria:

No immunodeficiency or contraindication to skin testing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Louisiana State University	New Orleans	Louisiana	United States	70112
2	University of Washington-Harborview Medical Center	Seattle	Washington	United States	98104

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jonathan M Zenilman, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT04620746

Other Study ID Numbers:

IRB00220384
HHSN272201300012I/HHSN27200015

First Posted:

Nov 9, 2020

Last Update Posted:

Aug 19, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Hypersensitivity

Drug Hypersensitivity

Penicillins

Penicillin G

Study Results

No Results Posted as of Aug 19, 2022