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Anti-infective Agent

Oral Penicillin Challenge for Penicillin Allergy (DOC Trial)

N/A
Recruiting
Research Sponsored by Northern Ontario School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals who suffer from pruritus (severe itching), with or without maculopapular rash after taking Amoxicillin
Be older than 18 years old
Must not have
Active asthma or any other illness that will increase the participants' risk
Individuals currently taking Beta Blockers, ACE inhibitors, antihistamines, or steroids at a dose greater than prednisone 10mg per day or equivalent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is evaluating a new clinic called the DOC that will be set up in Huntsville. It is for people in the Muskoka region who have a low-risk penicillin allergy. Participants will

Who is the study for?
This trial is for people in the Muskoka region with a low-risk penicillin allergy. Participants will join a clinic to challenge their allergy by taking penicillin under supervision and then provide feedback on their experience.
What is being tested?
The study tests whether direct oral challenges with low and standard doses of penicillin can safely remove the allergy label from patients' records. It also examines how this change affects antibiotic use over two years.
What are the potential side effects?
Possible side effects may include allergic reactions ranging from mild skin rashes to more severe responses, depending on individual sensitivity to penicillin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience severe itching or a rash after taking Amoxicillin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have asthma or another condition that could increase my risk.
Select...
I am currently taking Beta Blockers, ACE inhibitors, antihistamines, or steroids at a high dose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Are adequate participants available for DOC
Can a DOC operate in a rural community
Can participants be delableled through the DOC
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Low riskExperimental Treatment4 Interventions
Low risk patients will participate in the DOC challenge
Group II: High riskActive Control1 Intervention
Any participant defined as more than low risk will not receive the DOC

Find a Location

Who is running the clinical trial?

Northern Ontario School of MedicineLead Sponsor
10 Previous Clinical Trials
822 Total Patients Enrolled
Malcolm Wilson, MDStudy DirectorMuskoka Algonquin Healthcare
~48 spots leftby Nov 2025