Allergy AmoxicillinPhase 1NCT06823154
The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department
A Phase 1 study testing Amoxicillin and Study questionnaire in people with Allergy Amoxicillin and Beta-lactam Allergy Labels, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Allergy Amoxicillin, Beta-lactam Allergy Labels
- What is being tested?
- Amoxicillin and Study questionnaire
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2023to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Parent/guardian and/or patient unable to consent or assent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department: The De-Label Program Expansion
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.
- Conditions
- Allergy Amoxicillin, Beta-lactam Allergy Labels
- Being tested
- Amoxicillin, Study questionnaire
- Keywords
- Beta-lactam allergy labels, Pediatrics, Oral challenge, Emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Prospective cohort study of patients presenting to the emergency department with a reported beta-lactam allergy. (1) Allergy history and risk assessment, (2) Oral provocation challenge (if eligible), and (3) Post-discharge follow-up (if received oral provocation challenge or referred to allergy).
Study questionnaireOther
In the first component of the study, research staff will survey patients for history pertinent to their beta-lactam allergy label. This includes questions regarding any prior evaluations, patients' perception of their allergy label, and clinical details of allergy history. The latter involves an allergy history risk assessment, which will screen patient for high-risk features (eg, new maculopapular rash within 2 hours of administering antibiotic). Presence of any high-risk features will disqualify the patient from subsequent study components.
Finally, the questionnaire will screen for presence of any clinical confounders that would preclude administration of the oral provocation challenge (eg, use of antihistamines within prior 72 hours).
| Study group | Role | What they receive |
|---|---|---|
| Eligible for study risk assessment questionnaire | Experimental | 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 oral provocation challenge for allergy delabeling. Patients' ineligible for oral provocation challenge because of history of high-risk allergy symptoms or presence of clinical confounders for oral provocation challenge (eg, uncontrolled asthma) will be referred to the SickKids allergy clinic for further evaluation. Receives: Other: Study questionnaire |
| Eligible for oral challenge in the emergency department | Experimental | 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 oral provocation challenge), (2) have a previously unevaluated allergy label without high-risk features and without any clinical confounders for the oral provocation challenge, and (3) meet other clinical criteria for oral provocation challenge (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. Receives: Drug: Amoxicillin; Other: Study questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the proportion of patients delabeled among those given the oral provocation challenge.
In the primary analysis, successful beta-lactam allergy removal will be defined as tolerating oral provocation challenge without any immediate adverse reaction.
Measured: Up to 2 weeks
Secondary outcomes (6)
The proportion of patients with a reported BLA who are low risk (potential impact)
This includes questions regarding any prior evaluations, patients' perception of their allergy label, and clinical details of allergy history. The latter involves an allergy history risk assessment, which will screen patient for high-risk features (eg, new maculopapular rash within 2 hours of administering antibiotic). Presence of any high-risk features will disqualify the patient from subsequent study components.
Finally, the questionnaire will screen for presence of any clinical confounders that would preclude administration of the OPC (eg, use of antihistamines within prior 72 hours).
Measured: Day 1
The proportion of patients successfully delabeled without any adverse reactions (immediate or delayed up to 2 weeks)
Successful BLA removal will be defined as tolerating OPC without any immediate adverse reaction.
Measured: Up to 2 weeks
The proportion of patients who receive or are prescribed amoxicillin or a first-generation cephalosporin, among patients who undergo OPC
Measured: Day 1
Feasibility based on proportion of eligible participants who consent to OPC
Measured: Up to 2 weeks
Feasibility based on duration of allergy risk assessment and OPC (calculated using CRF timestamps)
Measured: Up to 2 weeks
Patient and caregiver perspectives on BLA and OPC
After completion of the oral challenge, participants and their caregivers will complete a study questionnaire to assess their opinions about the safety of the oral challenge and their comfortability with having the allergy label removed from their chart.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start27 Nov 2023
- Primary completion17 Feb 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy AmoxicillinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Science, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823154
- Sponsor's protocol ID
- 1000069700
- Status last verified
- Apr 2026
- First submitted
- 25 Jun 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department: The De-Label Program Expansion
- ClinicalTrials.gov ID
- NCT06823154
- Acronym / sponsor ID
- 1000069700
- Conditions
- Allergy Amoxicillin, Beta-lactam Allergy Labels
- Keywords
- Beta-lactam allergy labels, Pediatrics, Oral challenge, Emergency department
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eligible for study risk assessment questionnaire | Experimental | Other: Study questionnaireFirst, 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 oral provocation challenge for allergy delabeling. Patients' ineligible for oral provocation challenge because of history of high-risk allergy symptoms or presence of clinical confounders for oral provocation challenge (eg, uncontrolled asthma) will be referred to the SickKids allergy clinic for further evaluation. |
| Eligible for oral challenge in the emergency department | Experimental | Drug: Amoxicillin, Other: Study questionnaireA 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 oral provocation challenge), (2) have a previously unevaluated allergy label without high-risk features and without any clinical confounders for the oral provocation challenge, and (3) meet other clinical criteria for oral provocation challenge (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 may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Parent/guardian and/or patient unable to consent or assent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmoxicillinProspective cohort study of patients presenting to the emergency department with a reported beta-lactam allergy. (1) Allergy history and risk assessment, (2) Oral provocation challenge (if eligible), and (3) Post-discharge follow-up (if received oral provocation challenge or referred to allergy). | Drug | Eligible for oral challenge in the emergency department |
| Study questionnaireIn the first component of the study, research staff will survey patients for history pertinent to their beta-lactam allergy label. This includes questions regarding any prior evaluations, patients' perception of their allergy label, and clinical details of allergy history. The latter involves an allergy history risk assessment, which will screen patient for high-risk features (eg, new maculopapular rash within 2 hours of administering antibiotic). Presence of any high-risk features will disqualify the patient from subsequent study components. Finally, the questionnaire will screen for presence of any clinical confounders that would preclude administration of the oral provocation challenge (eg, use of antihistamines within prior 72 hours). | Other | Eligible for oral challenge in the emergency department, Eligible for study risk assessment questionnaire |
Primary outcome
The primary outcome will be the proportion of patients delabeled among those given the oral provocation challenge.
Time frame: Up to 2 weeks
In the primary analysis, successful beta-lactam allergy removal will be defined as tolerating oral provocation challenge without any immediate adverse reaction.
6 secondary outcomes
The proportion of patients with a reported BLA who are low risk (potential impact)
Time frame: Day 1
The proportion of patients successfully delabeled without any adverse reactions (immediate or delayed up to 2 weeks)
Time frame: Up to 2 weeks
The proportion of patients who receive or are prescribed amoxicillin or a first-generation cephalosporin, among patients who undergo OPC
Time frame: Day 1
Feasibility based on proportion of eligible participants who consent to OPC
Time frame: Up to 2 weeks
Feasibility based on duration of allergy risk assessment and OPC (calculated using CRF timestamps)
Time frame: Up to 2 weeks
Patient and caregiver perspectives on BLA and OPC
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amoxicillin and Study questionnaire in people with Allergy Amoxicillin and Beta-lactam Allergy Labels, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be the proportion of patients delabeled among those given the oral provocation challenge. (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.