Evaluating a Direct Oral Penicillin Challenge in a Rural Community
Evaluation of Direct Oral Challenge Clinic in a Rural Ontario Setting - Pilot Project
This study is testing if a special clinic can safely give penicillin to people in Muskoka who are thought to have a low-risk allergy, to help clear up confusion about penicillin allergies and improve how antibiotics are prescribed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northern Ontario School of Medicine Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Huntsville, Ontarion) |
| Trial ID | NCT06192277 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the outcomes of a Direct Oral Challenge (DOC) clinic for patients with a low-risk penicillin allergy in the Muskoka region. Participants will undergo a screening process to confirm their low-risk status and will then be challenged with low and standard doses of penicillin. Feedback will be collected from participants and local primary care providers over a two-year period to evaluate the impact of the DOC clinic on patient outcomes and ongoing antimicrobial use. The study seeks to clarify misconceptions about penicillin allergies and improve antibiotic prescribing practices.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old from the Muskoka region with a self-reported or documented low-risk penicillin allergy.
Not a fit: Patients with a history of severe allergic reactions to penicillin or those who cannot recall the nature of their previous reactions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help safely reintroduce penicillin to patients with previously misunderstood allergies, improving treatment options.
How similar studies have performed: Other studies have shown success in similar approaches to evaluating penicillin allergies, indicating potential for positive outcomes in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Huntsville, Ontarion
- Muskoka Algonquin Healthcare — Huntsville, Ontarion, Canada (Recruiting)
Study contacts
- Study coordinator: Maggie Partya-Sitnik, BA
- Email: magdalena.sitnik@mahc.ca
- Phone: 705-789-0022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.