Penicillin AllergyPhase 4OPENNCT03404804
Oral Challenge in the Pediatric ED
A Phase 4 study testing Amoxicillin in people with Penicillin Allergy and Pediatric Emergency Medicine, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Our primary objective was to demonstrate the feasibility of utilizing a novel penicillin allergy questionnaire in the PED to identify a low-risk group of patients who will complete an oral challenge in the PED to test for an IgE-mediated allergic reaction. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Penicillin Allergy, Pediatric Emergency Medicine
- What is being tested?
- Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 4 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2-16 with a parent/guardian (hereafter termed parent) reported history of allergy to a penicillin antibiotic in which the reported allergic reaction occurred at least six months prior to the current PED visit.
- Only children well enough to be discharged to home at the conclusion of the PED visit are eligible.
Who cannot join
- Children will be excluded if they have a history of developmental delay or inability to communicate the effects of an allergic reaction (non-verbal).
- Any contraindication to allergy testing will also result in exclusion
- (i.e. history of a severe allergic reaction to skin tests,,
- anaphylaxis in the past six weeks,
- known pregnancy
- child has a history of a condition that requires a beta blocker medicine for cardiac conditions, high blood pressure, migraine headaches, or eye drops for glaucoma (e.g. propranolol, metoprolol, atenolol and Timoptic®, or Betoptic® eye drops).
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- Children who present to the PED with a rash, vomiting or current asthma symptoms including coughing, wheezing or breathing problems will also be excluded to ensure these do not mask reactions to an oral challenge.
- Patients deemed too acutely ill for participation (triage level 1 or 2 or as determined by the ED patient care team) will be excluded from the study.
- During this pilot study, we will exclude non-English speaking families. However, in subsequent studies we will include the non-English speaking population.
- Children who are wards of the state, in foster care or police custody or detention will be excluded.
- Children with any basal condition (trauma, infection, minor accidents, etc..) will be able to participate in the study provided they and their family are willing and do not meet the above-mentioned exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Penicillin Challenge in the Pediatric Emergency Department
Our primary objective was to demonstrate the feasibility of utilizing a novel penicillin allergy questionnaire in the PED to identify a low-risk group of patients who will complete an oral challenge in the PED to test for an IgE-mediated allergic reaction. This was a 3-site pediatric emergency department study in which we challenged patients who met specific inclusion and exclusion criteria and were deemed low-risk.
Original aims included:
Read more
Aim 1: Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit.
Aim 2: Conduct follow-up one day after oral challenge for all children and seven days after oral challenge for patients discharged with a prescription antibiotic to determine if a delayed or T-Cell mediated reaction occurs after exposure to multiple doses of penicillin or any other antibiotic prescribed at discharge.
Aim 3: Examine health care outcomes and prescription-related costs associated with illness treatment plans in children who are de-labeled as penicillin allergic after an oral challenge.
A secondary objective within the IRB protocol reports, "Our secondary objective is to examine whether health care outcomes and prescription-related costs are comparable between children who are de-labeled as penicillin allergic after an oral challenge compared to a standard of care group who are not challenged in the PED."
However, we never proceeded with enrolling patients with PCN allergy not challenged in the PED as it was planned for later in the study that did not come to fruition.
Read the detailed description
A convenience sample of children aged 2 to 16 years who presented to the pediatric emergency department with a reported PCN allergy were administered an allergy questionnaire to determine risk-level designation. Low-risk eligible patients were offered an oral amoxicillin challenge. Differences among sites for family and provider interest in participation with oral challenges were analyzed.
- Conditions
- Penicillin Allergy, Pediatric Emergency Medicine
- Being tested
- Amoxicillin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy
| Study group | Role | What they receive |
|---|---|---|
| Oral Challenge | Experimental | Patients with low-risk symptoms of amoxicillin allergy who receive oral amoxicillin to delabel their respective allergy. Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oral Amoxicillin Challenge Participants Completing Challenge With Insignificant Adverse Result
Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit with insignificant adverse result.
Measured: 1 and 7 day followup phone surveys were conducted.
Secondary outcomes (1)
Number of Participants With Oral Amoxicillin Challenge Follow-up to Determine if a Delayed or T-Cell Mediated Reaction Occurs After Exposure
Conduct follow-up 6 months and 12 months after oral challenge for all children after oral challenge for patients discharged with a prescription antibiotic to determine if a delayed or T-Cell mediated reaction occurs after exposure to multiple doses of penicillin or any other antibiotic prescribed at discharge.
Measured: 6 months and 12 months after oral challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start4 Dec 2017
- Primary completion4 Dec 2020
- Study completion4 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Penicillin AllergyStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Edward Vyles, Medical College of Wisconsin
- Investigators
- David E Vyles, DO, MS, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404804
- Sponsor's protocol ID
- 1069530-3
- Acronym
- OPEN
- Status last verified
- Apr 2024
- First submitted
- 12 Jan 2018
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vyles D, Chiu A, Routes J, Castells M, Phillips EJ, Visotcky A, Fraser R, Pezzin L, Brousseau DC. Oral amoxicillin challenges in low-risk children during a pediatric emergency department visit. J Allergy Clin Immunol Pract. 2020 Mar;8(3):1126-1128.e1. doi: 10.1016/j.jaip.2019.09.022. Epub 2019 Oct 3. No abstract available.
PubMed 31586667
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Penicillin Challenge in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT03404804
- Acronym / sponsor ID
- OPEN / 1069530-3
- Conditions
- Penicillin Allergy, Pediatric Emergency Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 4 Dec 2022 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our primary objective was to demonstrate the feasibility of utilizing a novel penicillin allergy questionnaire in the PED to identify a low-risk group of patients who will complete an oral challenge in the PED to test for an IgE-mediated allergic reaction. This was a 3-site pediatric emergency department study in which we challenged patients who met specific inclusion and exclusion criteria and were deemed low-risk.
Original aims included:
Aim 1: Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit.
Aim 2: Conduct follow-up one day after oral challenge for all children and seven days after oral challenge for patients discharged with a prescription antibiotic to determine if a delayed or T-Cell mediated reaction occurs after exposure to multiple doses of penicillin or any other antibiotic prescribed at discharge.
Aim 3: Examine health care outcomes and prescription-related costs associated with illness treatment plans in children who are de-labeled as penicillin allergic after an oral challenge.
A secondary objective within the IRB protocol reports, "Our secondary objective is to examine whether health care outcomes and prescription-related costs are comparable between children who are de-labeled as penicillin allergic after an oral challenge compared to a standard of care group who are not challenged in the PED."
However, we never proceeded with enrolling patients with PCN allergy not challenged in the PED as it was planned for later in the study that did not come to fruition.
Detailed description
A convenience sample of children aged 2 to 16 years who presented to the pediatric emergency department with a reported PCN allergy were administered an allergy questionnaire to determine risk-level designation. Low-risk eligible patients were offered an oral amoxicillin challenge. Differences among sites for family and provider interest in participation with oral challenges were analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Challenge | Experimental | Drug: AmoxicillinPatients with low-risk symptoms of amoxicillin allergy who receive oral amoxicillin to delabel their respective allergy. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 2-16 with a parent/guardian (hereafter termed parent) reported history of allergy to a penicillin antibiotic in which the reported allergic reaction occurred at least six months prior to the current PED visit.
- Only children well enough to be discharged to home at the conclusion of the PED visit are eligible.
Key exclusion criteria (11 listed)
- Children will be excluded if they have a history of developmental delay or inability to communicate the effects of an allergic reaction (non-verbal).
- Any contraindication to allergy testing will also result in exclusion
- (i.e. history of a severe allergic reaction to skin tests,,
- anaphylaxis in the past six weeks,
- known pregnancy
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 |
|---|---|---|
| AmoxicillinOral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy | Drug | Oral Challenge |
Primary outcome
Number of Oral Amoxicillin Challenge Participants Completing Challenge With Insignificant Adverse Result
Time frame: 1 and 7 day followup phone surveys were conducted.
Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit with insignificant adverse result.
1 secondary outcome
Number of Participants With Oral Amoxicillin Challenge Follow-up to Determine if a Delayed or T-Cell Mediated Reaction Occurs After Exposure
Time frame: 6 months and 12 months after oral challenge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31586667Vyles D, Chiu A, Routes J, Castells M, Phillips EJ, Visotcky A, Fraser R, Pezzin L, Brousseau DC. Oral amoxicillin challenges in low-risk children during a pediatric emergency department visit. J Allergy Clin Immunol Pract. 2020 Mar;8(3):1126-1128.e1. doi: 10.1016/j.jaip.2019.09.022. Epub 2019 Oct 3. No abstract available.
- 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.
David E Vyles, DO, MS principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin in people with Penicillin Allergy and Pediatric Emergency Medicine, run by Medical College of Wisconsin at 1 site in United States.
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 2 inclusion and 11 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: finished, as of the sponsor's last update on 16 May 2024. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Oral Amoxicillin Challenge Participants Completing Challenge With Insignificant Adverse Result (time frame: 1 and 7 day followup phone surveys were conducted.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404804, which also lists 1 linked publication.
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 16 May 2024.