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Can we unlabel 'Allergic' kids in the ER? new study says maybe

NCT ID NCT06823154

Symptom relief Sponsor: The Hospital for Sick Children Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

Many children are incorrectly labeled as allergic to common antibiotics like amoxicillin, often due to rashes that are not true allergies. This study tests a program in the emergency department where low-risk children receive an oral challenge to see if they can safely tolerate the antibiotic. Researchers will track how many kids get their allergy label removed and follow up afterward. The goal is to improve antibiotic use and reduce unnecessary avoidance of effective medicines.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amoxicillin
What this could lead to
If successful, this program could safely remove unnecessary allergy labels for many children, allowing them to use first-line antibiotics when needed.
What could go wrong
This is an early-phase implementation study, not a randomized trial. Results may not apply to all settings, and some children could have a true allergic reaction during the oral challenge.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All paediatric patients aged 1 month to 18 years who present to the SickKids ED with a reported BLA will be eligible for the allergy history component of the study. Exclusion Criteria: * Parent/guardian and/or patient unable to consent or assent.

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Conditions

The condition(s) this trial relates to.

drug allergy Emergencies

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Allergy amoxicillin Beta-lactam allergy labels

Contacts and locations

Locations

  • Monica Caldeira-Kulbakas

    Toronto, Ontario, M5G1X8, Canada