Evaluation of a Direct Oral Penicillin Challenge in a Rural Community (DOC)

Northern Ontario School of Medicine

Status: Enrolling

Conditions: Allergy Penicillin

Treatments: Other: Remove allergy label; Drug: Standard dose Penicillin; Drug: Low dose Penicillin; Other: Screening

Study type: Interventional

Funder types: Other

Identifiers

NCT06192277

DOC

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Low risk

Experimental group

Description:

Low risk patients will participate in the DOC challenge

Treatment:

Other: Screening

Other: Remove allergy label

Drug: Standard dose Penicillin

Drug: Low dose Penicillin

High risk

No Intervention group

Description:

Any participant defined as more than low risk will not receive the DOC