Clinical trial NCT06192277: Evaluation of a Direct Oral Penicillin Challenge in a Rural Community
Official title: Evaluation of Direct Oral Challenge Clinic in a Rural Ontario Setting - Pilot Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allergy Penicillin
Lead sponsor: Northern Ontario School of Medicine
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants are initially screened to confirm they are at a low risk of reacting to a direct oral penicillin challenge. Low-risk participants are provided oral penicillin and observed for a reaction. If no reaction occurs, (immediate or delayed up to 28 days) patients have their penicillin allergy removed from their electronic medical record with their primary care provider and the local hospital.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to evaluate the outcomes of a rural-DOC Pilot clinic which will be established in the Huntsville site of Muskoka Algonquin Healthcare. Patients from the Muskoka region who are confirmed to have a low-risk penicillin allergy are eligible for participation in the DOC clinic. Following their experience with the DOC, participation in this study will be voluntary and feedback will be requested from each participant, and local primary care providers. The feedback will be used to assess the impact of the DOC clinic on participants and the medical community over the 2 - year study. Feedback will also be collected to investigate ongoing antimicrobial use for those participants who were successfully delabeled. This will be accomplished by surveying participants at six and twelve months after their DOC.

Detailed description: Penicillin has a well-established role in treating clinical infections in humans and animals. It was the first antibiotic to be mass produced and is still used worldwide. Modifications to the penicillin molecule have yielded derivatives with activity against a broader range of bacteria. However, one of the major limitations to use of penicillin is the incidence of allergic reactions to the drug. Penicillin allergies are reported in more than 10% of outpatients and 15% of inpatients. However, more than 30% of patients have no recollection of the symptoms of their adverse reaction to a medication and the inaccurate or inadequate documentation of adverse reactions can lead to misunderstood allergies. This study will challenge low risk participants to determine if they can safely take penicillin

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

Primary outcomes:
measure: Can a DOC operate in a rural community
timeFrame: 1 year
measure: Are adequate participants available for DOC
timeFrame: 1 year
measure: Can participants be delableled through the DOC
timeFrame: 1 year
measure: Number of Reactions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: Canada
facility: Muskoka Algonquin Healthcare
state: Ontarion
Study officials:
affiliation: Muskoka Algonquin Healthcare
name: Malcolm Wilson, MD
role: STUDY_DIRECTOR
References: