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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Allergy Penicillin
• Intervention / Treatment: Other: Screening; Drug: Low dose Penicillin; Drug: Standard dose Penicillin; Other: Remove allergy label

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maggie Partya-Sitnik, BA; Phone Number: 705-789-0022; Email: magdalena.sitnik@mahc.ca

Study Locations

• Canada
  • Ontarion
    • Huntsville, Ontarion, Canada, P1H1H7
      • Recruiting
      • Muskoka Algonquin Healthcare
      • Contact: Lisa Allen; Phone Number: 7056622901; Email: lisa.allen@mahc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low risk; Low risk patients will participate in the DOC challenge	Other: Screening; Patients are screened to confirm they are low risk for a penicillin allergy; Other Names: No treatment; 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.
No Intervention: High risk; Any participant defined as more than low risk will not receive the DOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Can a DOC operate in a rural community	Report on the number of staff available and who participate, and report on facility availability	1 year
Are adequate participants available for DOC	Report on the number of participants who contact the DOC for participation	1 year
Can participants be delableled through the DOC	Report on the number of participants who complete the DOC and are delabeled	1 year
Number of Reactions	Report on the number and type of reaction. Report the number of participants who are not delabeled.	1 year

Collaborators and Investigators

• Sponsor: Northern Ontario School of Medicine
• Investigators: Study Director: Malcolm Wilson, MD, Muskoka Algonquin Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Penicillins
• Other Study ID Numbers: DOC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share deidentified study data as requested
• IPD Sharing Time Frame: 6 months after the study closes for as long as
• IPD Sharing Access Criteria: Request to PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No