Status:
RECRUITING
Evaluation of a Direct Oral Penicillin Challenge in a Rural Community
Lead Sponsor:
Northern Ontario School of Medicine
Conditions:
Allergy Penicillin
Eligibility:
All Genders
18+ years
Phase:
NA
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 confirme...
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 penicill...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
Key Trial Info
Start Date :
October 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06192277
Start Date
October 6 2023
End Date
December 15 2024
Last Update
January 5 2024
Active Locations (1)
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1
Muskoka Algonquin Healthcare
Huntsville, Ontarion, Canada, P1H1H7