Active not recruitingPHASE1INTERVENTIONAL

The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department

This study aims to help children in the Emergency Department who have been told they have an allergy to amoxicillin or similar antibiotics, such as penicillin. These antibiotics are very common and usually work best with fewer side effects. Sometimes, children develop rashes days or weeks after taking these medicines, which can be mistaken for an allergic reaction. This study hopes to safely check if these children are truly allergic. By using a supervised 'oral challenge' (giving a small amount of the medicine and watching for reactions), they aim to 'de-label' children who aren't actually allergic. This means those children can then safely use these important antibiotics in the future, if needed.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

The Hospital for Sick Children

Enrolment target

500

Start

27 Nov 2023

Estimated completion

31 Dec 2026

Allergy Amoxicillin Beta-lactam Allergy Labels

What is this study about?

This study is about a common problem where children are thought to have an allergy to certain antibiotics, like amoxicillin or penicillin, which belong to a group called beta-lactams. These antibiotics are often the best choice for treating infections because they are very effective and usually have fewer side effects than other medicines. However, sometimes children get a rash days or even weeks after taking these antibiotics. This rash can be confused with an allergic reaction, even though it often isn't a true allergy.

When a child is wrongly labelled as allergic, it can mean they miss out on the best treatment options in the future. This study is setting up a special program in the Emergency Department at SickKids hospital to help figure out if children who have a suspected allergy are indeed allergic or not. They hope to remove these 'allergy' labels where appropriate.

They do this through a careful process called an 'oral challenge.' This means giving a small, carefully monitored dose of the antibiotic to see if the child actually has a reaction under medical supervision. If there's no reaction, it helps confirm they are not truly allergic. This approach has worked well for children staying in hospital, and now they want to see if it can help children coming into the Emergency Department too. The main goal is to make sure children can safely receive the best available antibiotics when they need them.

Key takeaways

Many children are wrongly labelled as allergic to amoxicillin or penicillin.
This study aims to safely check if these allergies are real, in an Emergency Department setting.
Removing a wrong allergy label means better treatment options for your child in the future.
The process involves careful questioning and sometimes a supervised 'oral challenge' with the medicine.
This study focuses on children aged 1 month to 18 years at SickKids ED.

Who may be eligible?

To take part in the first part of this study (where they ask about your child's allergy history), your child must be between 1 month and 18 years old. They also need to be visiting the SickKids hospital Emergency Department and have a suspected allergy to a beta-lactam antibiotic, like amoxicillin.

However, not every child will be able to take part in the 'de-labelling' part of the study (where they might give the medicine to check for an allergy). If the parent or guardian, or the child themselves (if they're old enough), can't understand or agree to take part, they won't be able to join.

They are interested in children of all genders for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 1 month and 18 years?
Is your child currently visiting the SickKids Emergency Department?
Does your child have a suspected earlier reaction to amoxicillin or penicillin?
Are you able to understand the study information and give your permission for your child to take part?

Answer every question to see your result.

What does participation involve?

If your child is thought to have an allergy to amoxicillin or similar antibiotics and comes to the SickKids Emergency Department, you might be asked to take part. The first step involves answering questions about your child's suspected allergy. This might be followed, if appropriate and safe, by a supervised 'oral challenge.' This means your child would be given a small dose of the antibiotic under strict medical observation to see if they react. If there's no reaction, it helps confirm they are not allergic. The total time for this process, including observation, would happen during your visit to the Emergency Department.

Potential risks and benefits

The potential benefits are that if your child is found not to be genuinely allergic, they can safely receive the best and often most effective antibiotics in the future, avoiding less suitable alternatives. This can improve their treatment options. The main risk involved in an 'oral challenge' is the possibility of a real allergic reaction; however, this is done in a controlled hospital environment with medical staff ready to manage any reactions immediately. You always have the right to withdraw your child from the study at any time without affecting their medical care.

Locations (1)

Monica Caldeira-Kulbakas
Verified postcode
Toronto, Canada

Common questions

What is an 'allergy de-labelling program'?

It's a way to safely check if someone is truly allergic to a medicine, or if their 'allergy label' was a mistake, so they can use the medicine if needed.

Why is it important to remove a wrong 'allergy' label?

It means your child can get the best and most effective antibiotics when they are sick, which often work better and have fewer side effects.

What is an 'oral challenge'?

It's a test where a small amount of the suspected medicine is given under close medical watch to see if there's a reaction, confirming if an allergy is real.

Are penicillin and amoxicillin similar?

Yes, amoxicillin is a type of penicillin, and they are both common antibiotics often used for children.

Who can take part in this study?

Children aged 1 month to 18 years visiting the SickKids Emergency Department with a suspected amoxicillin or penicillin allergy.