Allergy De-Labeling for Amoxicillin Allergy

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: The Hospital for Sick Children

Disqualifiers: Unable to consent or assent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

191 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 4 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Eligible for study risk assessment questionnaire Experimental Treatment 1 Intervention

First, a systematic allergy risk assessment tool will enable stratification of patients' reported symptoms as (1) low risk (eg, isolated urticarial, maculopapular rash, gastrointestinal symptoms) or (2) high risk (eg, anaphylaxis, severe systemic reactions). Only patients classified low risk will be eligible for OPC for allergy delabeling. Patients' ineligible for OPC because of history of high-risk allergy symptoms or presence of clinical confounders for OPC (eg, uncontrolled asthma) will be referred to the SickKids allergy clinic for further evaluation.

Group II: Eligible for oral challenge in the emergency department Experimental Treatment 2 Interventions

A subset of patients screened with the risk assessment questionnaire will fulfill eligibility criteria to undergo the Oral provocation challenge. Specifically, these will be patients who (1) fulfill several procedural requirements (eg, parent able to observe child for 1 hour after OPC), (2) have a previously unevaluated allergy label without high-risk features and without any clinical confounders for the OPC, and (3) meet other clinical criteria for OPC (eg, vital signs within normal range). These participants will be given a one-time dose of Amoxicillin 17 mg/kg (maximum, 500 mg) and observed for 1 hour for a reaction.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive factors of amoxicillin immediate hypersensitivity and validation of PEN-FAST clinical decision rule. Piotin, A., Godet, J., Trubiano, JA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Review of Pharmacist Driven Penicillin Allergy Assessments and Skin Testing: A Multi-Center Case-Series. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Removal of incorrect penicillin allergy labels in a UK hospital. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness and Feasibility of Pharmacist-Driven Penicillin Allergy De-Labeling Pilot Program without Skin Testing or Oral Challenges. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Drug Allergy Delabeling Programs: Recent Strategies and Targeted Populations. [2022]

5. Thailand pubmed.ncbi.nlm.nih.gov

Prevalence of antibiotic allergy labels and their consequences in people presenting to a teaching hospital Emergency Department; a retrospective chart review. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Antimicrobial stewardship intervention: optimizing antibiotic treatment in hospitalized patients with reported antibiotic allergy. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Barriers to penicillin allergy de-labeling in the inpatient and outpatient settings: a qualitative study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The 3 Cs of Antibiotic Allergy-Classification, Cross-Reactivity, and Collaboration. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Predictive factors of amoxicillin immediate hypersensitivity and validation of PEN-FAST clinical decision rule. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The democratization of de-labeling: a review of direct oral challenge in adults with low-risk penicillin allergy. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Antibiotic Allergy in Pediatrics. [2022]