Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
284
Skin testing followed by oral challenge with amoxicillin 250 mg single dose
Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Louisiana State University
New Orleans, Louisiana, United States
University of Washington-Harborview Medical Center
Seattle, Washington, United States
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
Time frame: 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
Time frame: 30 minutes after intervention
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.
Time frame: Immediately after intervention
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.
Time frame: 18 months
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