191 Participants Needed

Allergy De-Labeling for Amoxicillin Allergy

Age: < 65
Sex: Any
Trial Phase: Phase 1
Sponsor: The Hospital for Sick Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Beta-lactams are the most common antibiotics prescribed to children, including penicillin and amoxicillin. They are usually more effective and have fewer side effects than other ty antibiotics. Some children can have reactions to these antibiotics that can be mistaken as an allergy, especially rashes that develop days to weeks later. In such cases, when children take the antibiotic again, they have no problem tolerating it; this is called "delabeling an allergy" with an "oral challenge". Based on our experience with a similar program among inpatients, we are implementing and evaluating an allergy delabeling program for children in the SickKids ED, with the hope and intent to delabel most children of their "allergies" using an oral challenge.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is the Allergy De-Labeling for Amoxicillin Allergy treatment safe for humans?

Research shows that penicillin allergy de-labeling, including amoxicillin challenges, is generally safe. In a study, no patients experienced a reaction from penicillin allergy skin testing or oral amoxicillin challenges, suggesting that these procedures are safe for most people.12345

How does the drug for amoxicillin allergy de-labeling differ from other treatments?

The amoxicillin allergy de-labeling treatment is unique because it involves a direct oral challenge, which is a quick and cost-effective method to confirm or rule out an allergy, unlike traditional methods that may rely on skin testing or avoidance. This approach helps to accurately identify patients who are not truly allergic, allowing them to safely use amoxicillin and other related antibiotics, which are often more effective and less costly.46789

What data supports the effectiveness of the Allergy De-Labeling Program for amoxicillin allergy?

Research shows that pharmacist-driven penicillin allergy assessments, including skin testing and oral challenges, are effective in safely removing incorrect penicillin allergy labels. In one study, 89% of patients had their penicillin allergies de-labeled without experiencing any adverse reactions, suggesting that similar methods could be effective for amoxicillin allergy de-labeling.2461011

Are You a Good Fit for This Trial?

This trial is for children who have been labeled with an allergy to antibiotics like penicillin or amoxicillin, but might not truly be allergic. They should be visiting the emergency department and willing to undergo an 'oral challenge' to potentially remove the allergy label.

Inclusion Criteria

I am between 1 month and 18 years old and have a reported bee sting allergy.

Exclusion Criteria

I or my guardian cannot give consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Risk Assessment

Systematic allergy risk assessment to stratify patients' reported symptoms as low or high risk

1 day
1 visit (in-person)

Oral Challenge

Eligible patients undergo an oral provocation challenge with Amoxicillin and are observed for 1 hour

1 day
1 visit (in-person)

Follow-up

Participants are monitored for any adverse reactions up to 2 weeks after the oral challenge

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Allergy De-Labeling Program
Trial Overview The study is testing a program where children in the emergency department are given a questionnaire and then take amoxicillin under supervision. The goal is to see if they can tolerate it without allergic reactions, effectively 'delabeling' their supposed allergy.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Eligible for study risk assessment questionnaireExperimental Treatment1 Intervention
Group II: Eligible for oral challenge in the emergency departmentExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials
724
Recruited
6,969,000+

Published Research Related to This Trial

The PEN-FAST clinical decision rule effectively identifies low-risk penicillin allergies in a high-risk population, with a strong discrimination ability (AUC of 0.86) based on a study of 142 patients, most of whom reported anaphylaxis.
Using a cutoff of less than 3 points on the PEN-FAST score, only 6.9% of patients classified as low risk tested positive for an allergy, demonstrating a high negative predictive value (0.93) for safely delabeling amoxicillin allergy.
Predictive factors of amoxicillin immediate hypersensitivity and validation of PEN-FAST clinical decision rule.Piotin, A., Godet, J., Trubiano, JA., et al.[2022]

Citations

Review of Pharmacist Driven Penicillin Allergy Assessments and Skin Testing: A Multi-Center Case-Series. [2023]
Removal of incorrect penicillin allergy labels in a UK hospital. [2023]
Effectiveness and Feasibility of Pharmacist-Driven Penicillin Allergy De-Labeling Pilot Program without Skin Testing or Oral Challenges. [2021]
Drug Allergy Delabeling Programs: Recent Strategies and Targeted Populations. [2022]
Prevalence of antibiotic allergy labels and their consequences in people presenting to a teaching hospital Emergency Department; a retrospective chart review. [2021]
Antimicrobial stewardship intervention: optimizing antibiotic treatment in hospitalized patients with reported antibiotic allergy. [2020]
Barriers to penicillin allergy de-labeling in the inpatient and outpatient settings: a qualitative study. [2023]
The 3 Cs of Antibiotic Allergy-Classification, Cross-Reactivity, and Collaboration. [2022]
Predictive factors of amoxicillin immediate hypersensitivity and validation of PEN-FAST clinical decision rule. [2022]
The democratization of de-labeling: a review of direct oral challenge in adults with low-risk penicillin allergy. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Antibiotic Allergy in Pediatrics. [2022]
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