Penicillin AllergyPhase 4NCT05563610
Oral Penicillin Challenge and Allergy De-labeling in Children
A Phase 4 study testing Amoxicillin 500mg in people with Penicillin Allergy, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
The primary purpose of this study is to investigate the portion of penicillin allergy labels that are not true allergies using oral amoxicillin challenges among pediatric patients. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Penicillin Allergy
- What is being tested?
- Amoxicillin 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to 12 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients in the pediatric emergency department who are 2-17 yo and labeled as penicillin-allergic (including amoxicillin or other penicillin allergies)
- Patients at low risk of anaphylaxis as determined by the study questionnaire
- Patients who would normally be prescribed amoxicillin, amoxicillin-clavulanate or another penicillin for their current bacterial infection, including otitis media, Group A Streptococcal pharyngitis, pneumonia. sinusitis, dog and cat bite wounds, regimens for Helicobacter pylori eradication, or other acute infections deemed susceptible.
- Patients who are interested in participating
- Patients who have an acceptable surrogate to give consent on the subject's behalf
- Patients whose surrogate (parent/caregiver) speaks English or Spanish
Who cannot join
- Patients who are uninterested in participating, or their parents/caregivers are not interested in having them participate
- Patients who have multiple drug allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Penicillin Challenge and Allergy De-labeling in the Phoenix Children's Hospital Emergency Department
The primary purpose of this study is to investigate the portion of penicillin allergy labels that are not true allergies using oral amoxicillin challenges among pediatric patients. The secondary purpose is to evaluate the safety and feasibility of administering oral penicillin allergy challenges in the Pediatric Emergency Department.
- Conditions
- Penicillin Allergy
- Being tested
- Amoxicillin 500mg
- Keywords
- penicillin, anaphylaxis, allergy, oral challenge, amoxicillin, pediatric, emergency department
- Medical subject headings
- Anaphylaxis, Hypersensitivity, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin 500mgDrug
Also called Oral Challenge
Patients screened to be low risk of penicillin allergy will be randomized to receive amoxicillin dose or not
| Study group | Role | What they receive |
|---|---|---|
| Oral Challenge | Experimental | Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to oral amoxicillin 500 mg challenge. Receives: Drug: Amoxicillin 500mg |
| No Oral Challenge | No intervention | Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to no oral amoxicillin 500 mg challenge.. |
What is being measured
The primary outcome is the main question the study is designed to answer.
True Penicillin Allergies
Percentage of study patients presenting to the pediatric ED who received the amoxicillin oral challenge who demonstrated a true IgE-mediated allergic reaction
Measured: 24 hours after amoxicillin oral challenge
Secondary outcomes (5)
Amoxicillin Oral Challenge Safety - High-Risk Reactions
Percentage of high-risk penicillin allergic reactions
Measured: 24 hours after amoxicillin oral challenge
Amoxicillin Oral Challenge Safety - Admissions
Percentage of admissions from the pediatric ED in patients experiencing high-risk penicillin allergic reactions
Measured: 24 hours after amoxicillin oral challenge
Amoxicillin Oral Challenge Safety - Re-admissions
Percentage of re-admissions from home after discharge from the pediatric ED in patients experiencing high-risk penicillin allergic reactions
Measured: 24 hours after amoxicillin oral challenge
Amoxicillin Oral Challenge Safety - Deaths
Percentage of deaths in patients experiencing high-risk penicillin allergic reactions
Measured: 24 hours after amoxicillin oral challenge
Amoxicillin Oral Challenge Feasibility
Average hospital length of stay in the pediatric ED for patients receiving the amoxicillin oral challenge relative to the non-treatment group
Measured: 24 hours after amoxicillin oral challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start26 Sep 2022
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Why it stopped: Unable to recruit sufficient number of subjects in the setting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diane E. Hindman, MD, Phoenix Children's Hospital
- Investigators
- Diane E Hindman, MD PharmD, Principal investigator, Emergency Department Attending Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563610
- Sponsor's protocol ID
- IRB-22-154
- Status last verified
- Jun 2024
- First submitted
- 27 Sep 2022
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers at this time.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Penicillin Challenge and Allergy De-labeling in the Phoenix Children's Hospital Emergency Department
- ClinicalTrials.gov ID
- NCT05563610
- Acronym / sponsor ID
- IRB-22-154
- Conditions
- Penicillin Allergy
- Keywords
- penicillin, anaphylaxis, allergy, oral challenge, amoxicillin, pediatric, emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient number of subjects in the setting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 3 Oct 2022 (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.
The primary purpose of this study is to investigate the portion of penicillin allergy labels that are not true allergies using oral amoxicillin challenges among pediatric patients. The secondary purpose is to evaluate the safety and feasibility of administering oral penicillin allergy challenges in the Pediatric Emergency Department.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Challenge | Experimental | Drug: Amoxicillin 500mgPatients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to oral amoxicillin 500 mg challenge. |
| No Oral Challenge | No intervention | –Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to no oral amoxicillin 500 mg challenge.. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients in the pediatric emergency department who are 2-17 yo and labeled as penicillin-allergic (including amoxicillin or other penicillin allergies)
- Patients at low risk of anaphylaxis as determined by the study questionnaire
- Patients who would normally be prescribed amoxicillin, amoxicillin-clavulanate or another penicillin for their current bacterial infection, including otitis media, Group A Streptococcal pharyngitis, pneumonia. sinusitis, dog and cat bite wounds, regimens for Helicobacter pylori eradication, or other acute infections deemed susceptible.
- Patients who are interested in participating
- Patients who have an acceptable surrogate to give consent on the subject's behalf
Key exclusion criteria (2 listed)
- Patients who are uninterested in participating, or their parents/caregivers are not interested in having them participate
- Patients who have multiple drug allergies
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 |
|---|---|---|
| Amoxicillin 500mgAlso: Oral ChallengePatients screened to be low risk of penicillin allergy will be randomized to receive amoxicillin dose or not | Drug | Oral Challenge |
Primary outcome
True Penicillin Allergies
Time frame: 24 hours after amoxicillin oral challenge
Percentage of study patients presenting to the pediatric ED who received the amoxicillin oral challenge who demonstrated a true IgE-mediated allergic reaction
5 secondary outcomes
Amoxicillin Oral Challenge Safety - High-Risk Reactions
Time frame: 24 hours after amoxicillin oral challenge
Amoxicillin Oral Challenge Safety - Admissions
Time frame: 24 hours after amoxicillin oral challenge
Amoxicillin Oral Challenge Safety - Re-admissions
Time frame: 24 hours after amoxicillin oral challenge
Amoxicillin Oral Challenge Safety - Deaths
Time frame: 24 hours after amoxicillin oral challenge
Amoxicillin Oral Challenge Feasibility
Time frame: 24 hours after amoxicillin oral challenge
Results and safety
The study was stopped early (reason given: Unable to recruit sufficient number of subjects in the setting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers at this time.
Related trials for Penicillin Allergy
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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.
Diane E Hindman, MD PharmD principal investigator
Emergency Department Attending Physician
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 500mg in people with Penicillin Allergy, run by Phoenix Children's Hospital 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 14 Jun 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?
The study was stopped early (reason given: Unable to recruit sufficient number of subjects in the setting). Results are not available in the source record.
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?
True Penicillin Allergies (time frame: 24 hours after amoxicillin oral challenge). 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 14 Jun 2024.