Evaluation of a Direct Oral Penicillin Challenge in a Rural Community

Allergy Penicillin Clinical Trial

— DOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192277
• Other study ID #: DOC
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: January 2024
• Source: Northern Ontario School of Medicine
• Contact: Maggie Partya-Sitnik, BA
• Phone: 705-789-0022
• Email: magdalena.sitnik[@]mahc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 15, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergy Penicillin

Intervention

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
• 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.

Locations

Country	Name	City	State
Canada	Muskoka Algonquin Healthcare	Huntsville	Ontarion

Sponsors (1)

Lead Sponsor	Collaborator
Northern Ontario School of Medicine

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Are adequate participants available for DOC	Report on the number of participants who contact the DOC for participation	1 year
Primary	Can participants be delableled through the DOC	Report on the number of participants who complete the DOC and are delabeled	1 year
Primary	Number of Reactions	Report on the number and type of reaction. Report the number of participants who are not delabeled.	1 year