Allergy Penicillin
Conditions
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
Interventions
OTHERScreening
Patients are screened to confirm they are low risk for a penicillin allergy
DRUGLow dose Penicillin
Low risk participants are given a low-dose of oral penicillin followed by 60 minutes of observation
DRUGStandard dose Penicillin
Participants who have taken the low dose of oral penicillin and have had no reaction are provided a second higher dose of penicillin (250mg) and observed for 60 minutes.
OTHERRemove allergy label
Participants who have no reaction after 28 days have their penicillin allergy label removed from their electronic medical record and hospital record.
Sponsors
Northern Ontario School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Can a DOC operate in a rural community | 1 year | Report on the number of staff available and who participate, and report on facility availability |
| Are adequate participants available for DOC | 1 year | Report on the number of participants who contact the DOC for participation |
| Can participants be delableled through the DOC | 1 year | Report on the number of participants who complete the DOC and are delabeled |
| Number of Reactions | 1 year | Report on the number and type of reaction. Report the number of participants who are not delabeled. |
Countries
Canada
Contacts
Primary ContactMaggie Partya-Sitnik, BA
Outcome results
None listed