NCT06192277

Evaluation of a Direct Oral Penicillin Challenge in a Rural Community

Evaluation of Direct Oral Challenge Clinic in a Rural Ontario Setting - Pilot Project

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Northern Ontario School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Allergy Penicillin

Interventions

Type	Name	Description
OTHER	Screening	Patients are screened to confirm they are low risk for a penicillin allergy
DRUG	Low dose Penicillin	Low risk participants are given a low-dose of oral penicillin followed by 60 minutes of observation
DRUG	Standard 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.
OTHER	Remove allergy label	Participants who have no reaction after 28 days have their penicillin allergy label removed from their electronic medical record and hospital record.

Timeline

• Start date: 2023-10-06
• Primary completion: 2024-09-30
• Completion: 2024-12-15
• First posted: 2024-01-05
• Last updated: 2024-01-05

Locations

1 site across 1 country: Canada