Back to resultsPenicillin Allergy Testing in STD Clinics
Primary Purpose
Penicillin Allergy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Penicillin Major Determinant (PrePen) Skin Testing
Direct Oral challenge
Sponsored by
About this trial
This is an interventional diagnostic trial for Penicillin Allergy
Eligibility Criteria
Inclusion Criteria:
- Prior history of PCN allergy
Exclusion Criteria:
- No immunodeficiency or contraindication to skin testing
Sites / Locations
- Louisiana State University
- University of Washington-Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Skin Testing Arm
Direct Oral Challenge
Arm Description
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04620746
First Posted
November 3, 2020
Last Updated
September 20, 2023
Sponsor
Johns Hopkins University
Collaborators
Indiana University School of Medicine, Wake Forest University Health Sciences, Louisiana State University Health Sciences Center in New Orleans, University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT04620746
Brief Title
Penicillin Allergy Testing in STD Clinics
Official Title
Validate an Easy to Administer Algorithm to Define Penicillin (PCN-B-lactam) Allergy Status in Sexually Transmitted Disease (STD) Clinic Outpatients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Indiana University School of Medicine, Wake Forest University Health Sciences, Louisiana State University Health Sciences Center in New Orleans, University of Washington
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penicillin Allergy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skin Testing Arm
Arm Type
Active Comparator
Arm Description
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge
Arm Title
Direct Oral Challenge
Arm Type
Active Comparator
Arm Description
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin
Intervention Type
Drug
Intervention Name(s)
Penicillin Major Determinant (PrePen) Skin Testing
Other Intervention Name(s)
Penicillin G Minor Determinant Skin Testing
Intervention Description
Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Intervention Type
Drug
Intervention Name(s)
Direct Oral challenge
Intervention Description
Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Primary Outcome Measure Information:
Title
Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study
Description
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
Time Frame
Baseline
Title
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
Description
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
Time Frame
30 minutes after intervention
Secondary Outcome Measure Information:
Title
Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire
Description
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.
Time Frame
Immediately after intervention
Title
Provider Assessment of Feasibility of Allergy Evaluation at the End of Study
Description
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.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Prior history of PCN allergy
Exclusion Criteria:
No immunodeficiency or contraindication to skin testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan M Zenilman
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louisiana State University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Washington-Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Penicillin Allergy Testing in STD Clinics
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