Amoxicillin AllergyPhase 4NCT05165212
Primary Care Amoxicillin Challenge
A Phase 4 study testing Amoxicillin in people with Amoxicillin Allergy, run by State University of New York at Buffalo.
Trial summary
The purpose of this project is to identify clinic patients reporting penicillin allergy who are low risk for allergic reaction, and then invite them to participate in an oral amoxicillin challenge in their primary office without need for referral to allergy/immunology. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Amoxicillin Allergy
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2024to 1 Jan 2026
- 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 Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients less than 18 years old who attend either of two hospital-affiliated general pediatric clinic sites who have an allergy to penicillin (or its derivatives) documented in their electronic medical record.
Who cannot join
- Patients who do not have an allergy to penicillin (or its derivatives) documented in their electronic medical record or patients with listed penicillin allergy whose parent/guardian declines to participate in the study. Patients will also be excluded if their penicillin allergy has been confirmed with either failed amoxicillin challenge or positive penicillin skin testing. Medically fragile children who cannot tolerate a direct oral challenge will be excluded but may be offered referral to allergy/immunology. If, on review of the history of the allergy, features of likely IgE mediated (onset in 1st hour of course or anaphylaxis requiring hospital care) or dangerous non-IgE mediated penicillin allergy (Stevens Johnson with penicillin, blistering rashes, penicillin related cytopenia) are obtained, these patients are also excluded from challenge but may be referred to allergy for further education and appropriate testing.
About this study
Official title: Oral Amoxicillin Challenge in the Primary Care Setting
The purpose of this project is to identify clinic patients reporting penicillin allergy who are low risk for allergic reaction, and then invite them to participate in an oral amoxicillin challenge in their primary office without need for referral to allergy/immunology. If the patient is able to tolerate oral amoxicillin, the antibiotic allergy in question will be removed from the patient's chart.
Read the detailed description
Patients with a documented allergy to amoxicillin, ampicillin, or penicillin who are deemed low-risk for true penicillin allergy based on history will be offered enrollment in the study. Patients will be scheduled for an oral amoxicillin challenge in the primary care office at a later date. During this challenge, patients will be given 10% of a weight-based dose of amoxicillin and then observed for 30 minutes for signs and symptoms of an allergic reaction. If no reaction occurs, they will be given the remaining 90% of the weight-based dose and observed for an additional 30 minutes. Emergency medications such as diphenhydramine and epinephrine will be immediately available if needed. If the patient completes oral amoxicillin challenge without a clinically significant reaction, penicillin (and/or amoxicillin/ampicillin) allergy will be removed from the patient's chart.
- Conditions
- Amoxicillin Allergy
- Being tested
- Amoxicillin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Patients will be given 10% of a standard weight-based dose of amoxicillin and observed for signs/symptoms of allergic reaction for 30 minutes. If no reaction occurs, they will given the remaining 90% of the standard dose and observed for an additional 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving one dose of amoxicillin. | Experimental | Patients receiving one dose of amoxicillin and then observed for one hour for signs/symptoms off allergic reaction. Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients reporting penicillin allergy
who are able to tolerate penicillin drug oral challenge in the primary care setting without prior referral to allergy/immunology.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start31 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Why it stopped: Unable to host study at clinic site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amoxicillin 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Joseph Hamilton, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165212
- Sponsor's protocol ID
- STUDY00006018
- Status last verified
- Oct 2023
- First submitted
- 20 Dec 2021
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Amoxicillin Challenge in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT05165212
- Acronym / sponsor ID
- STUDY00006018
- Conditions
- Amoxicillin Allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to host study at clinic site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 21 Dec 2021 (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 purpose of this project is to identify clinic patients reporting penicillin allergy who are low risk for allergic reaction, and then invite them to participate in an oral amoxicillin challenge in their primary office without need for referral to allergy/immunology. If the patient is able to tolerate oral amoxicillin, the antibiotic allergy in question will be removed from the patient's chart.
Detailed description
Patients with a documented allergy to amoxicillin, ampicillin, or penicillin who are deemed low-risk for true penicillin allergy based on history will be offered enrollment in the study. Patients will be scheduled for an oral amoxicillin challenge in the primary care office at a later date. During this challenge, patients will be given 10% of a weight-based dose of amoxicillin and then observed for 30 minutes for signs and symptoms of an allergic reaction. If no reaction occurs, they will be given the remaining 90% of the weight-based dose and observed for an additional 30 minutes. Emergency medications such as diphenhydramine and epinephrine will be immediately available if needed. If the patient completes oral amoxicillin challenge without a clinically significant reaction, penicillin (and/or amoxicillin/ampicillin) allergy will be removed from the patient's chart.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving one dose of amoxicillin. | Experimental | Drug: AmoxicillinPatients receiving one dose of amoxicillin and then observed for one hour for signs/symptoms off allergic reaction. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients less than 18 years old who attend either of two hospital-affiliated general pediatric clinic sites who have an allergy to penicillin (or its derivatives) documented in their electronic medical record.
Key exclusion criteria (1 listed)
- Patients who do not have an allergy to penicillin (or its derivatives) documented in their electronic medical record or patients with listed penicillin allergy whose parent/guardian declines to participate in the study. Patients will also be excluded if their penicillin allergy has been confirmed with either failed amoxicillin challenge or positive penicillin skin testing. Medically fragile children who cannot tolerate a direct oral challenge will be excluded but may be offered referral to allergy/immunology. If, on review of the history of the allergy, features of likely IgE mediated (onset in 1st hour of course or anaphylaxis requiring hospital care) or dangerous non-IgE mediated penicillin allergy (Stevens Johnson with penicillin, blistering rashes, penicillin related cytopenia) are obtained, these patients are also excluded from challenge but may be referred to allergy for further education and appropriate testing.
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 |
|---|---|---|
| AmoxicillinPatients will be given 10% of a standard weight-based dose of amoxicillin and observed for signs/symptoms of allergic reaction for 30 minutes. If no reaction occurs, they will given the remaining 90% of the standard dose and observed for an additional 30 minutes. | Drug | Patients receiving one dose of amoxicillin. |
Primary outcome
Percentage of patients reporting penicillin allergy
Time frame: 12 months
who are able to tolerate penicillin drug oral challenge in the primary care setting without prior referral to allergy/immunology.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin in people with Amoxicillin Allergy, run by State University of New York at Buffalo.
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: withdrawn, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Percentage of patients reporting penicillin allergy (time frame: 12 months). 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 18 Oct 2023.