Evaluation of a Direct Oral Penicillin Challenge in a Rural Community

Launched by NORTHERN ONTARIO SCHOOL OF MEDICINE · Jan 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new clinic in Huntsville, Muskoka, that focuses on safely testing patients with a low-risk penicillin allergy. The goal is to see how effective this clinic is in helping people who believe they are allergic to penicillin but may not actually be. If you live in the Muskoka region, are over 18, and have a history of a low-risk penicillin allergy, you might be eligible to participate. To qualify, you should not have had any severe reactions to penicillin in the past 10 years and should be in stable health.

As a participant, you will undergo a direct oral penicillin challenge (DOC), which means you will be closely monitored while taking penicillin to see how your body reacts. Your feedback, along with that of your healthcare providers, will be collected over two years to understand the impact of this clinic on patients and the community. Additionally, you will be surveyed six and twelve months after your challenge to track how your antibiotic use changes. This study is an important step in helping people who think they have a penicillin allergy safely receive this common and often necessary medication.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Individuals in the Muskoka region, residing in the catchment area of Muskoka Algonquin Healthcare (Huntsville and South Muskoka site) who meet the following criteria are eligible for the study.
• Inclusion Criteria:
• • Greater than 18 years of age
• • In stable health
• • Penicillin allergy that is either self-reported, reported by their primary care provider or previously documented in their electronic medical record
• • Successfully screened to ensure they are low-risk for a penicillin allergy and have a PEN-FAST score of \<3
• Screening Criteria:
• • Did not react to penicillin in the past 10 years
• • Was never hospitalized with a penicillin reaction
• • Have no evidence of a Severe Cutaneous Adverse Reaction (SCAR)
• • Have no evidence of a Drug-Related Eosinophilia and Systemic Symptoms (DRESS)
• • Have no history of Asthma
• • Cannot recall the nature of the penicillin reaction
• • Have a history of isolated non-allergic symptoms (eg. GI upset only)
• • Only have a family history of penicillin reaction
• • If suffer from pruritus (severe itching), with or without maculopapular rash after taking Amoxicillin
• • Have no history of IgE mediated hypersensitivity reaction or angioedema
• Exclusion Criteria:
• • Pregnancy
• • Active asthma or any other illness that will increase the participants' risk
• • Do not meet the low-risk screening criteria
• • Individuals who report an immune-mediated reaction to cephalosporins
• • Currently taking Beta Blockers, ACE inhibitors, antihistamines or steroids at a dose greater than prednisone 10mg per day or equivalent
• • If study physicians deem them not to be in stable health