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OpenTrials
Completed

NCT Number: NCT04620746

Penicillin Allergy Testing in STD Clinics

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

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Key information

Conditions

Penicillin Allergy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Louisiana State University, New Orleans, Louisiana, United States

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About this study

all subjects receive risk questionnaire For subjects without high risk responses, randomized to direct oral challenge or PCN skin testing followed by oral challenge

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prior history of PCN allergy

Exclusion criteria

  • No immunodeficiency or contraindication to skin testing

Treatment and study plan

Penicillin Major Determinant (PrePen) Skin Testing

Drug

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

Other names: Penicillin G Minor Determinant Skin Testing

Direct Oral challenge

Drug

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

Primary outcomes

  1. Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study

    Time frame: Baseline

    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

  2. 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

    Time frame: 30 minutes after intervention

    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 outcomes

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

    Time frame: Immediately after intervention

    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.

  2. Provider Assessment of Feasibility of Allergy Evaluation at the End of Study

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Indiana University
  • Louisiana State University Health Sciences Center in New Orleans
  • University of Washington
  • Wake Forest University Health Sciences

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2020
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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