Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge
NCT ID: NCT06303128
Last Updated: 2025-05-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
380 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-02-03
Study Completion Date
2026-12-31
Brief Summary
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The goal of this clinical trial is to learn about dosing when testing to see if a penicillin allergy label can be removed from adults that had been labeled as "penicillin-allergic" previously. The main question it aims to answer is:
\- In penicillin-allergic patients that are at low risk of having an allergic reaction, is a one-dose oral challenge with amoxicillin (a penicillin-based antibiotic) as safe and effective as a two-dose oral challenge?
Participants will, after being identified as having a low-risk penicillin allergy, be administered oral amoxicillin in a controlled setting and then monitored for an allergic reaction. Researchers will compare participants that took one dose of amoxicillin to participants that took two doses of amoxicillin (a small dose and then a larger dose) to see if either group was more likely to develop an allergic reaction.
\- In penicillin-allergic patients that are at low risk of having an allergic reaction, is a one-dose oral challenge with amoxicillin (a penicillin-based antibiotic) as safe and effective as a two-dose oral challenge?
Participants will, after being identified as having a low-risk penicillin allergy, be administered oral amoxicillin in a controlled setting and then monitored for an allergic reaction. Researchers will compare participants that took one dose of amoxicillin to participants that took two doses of amoxicillin (a small dose and then a larger dose) to see if either group was more likely to develop an allergic reaction.
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Detailed Description
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Anywhere from 5-15% of patients have a reported penicillin allergy listed in their medical record. However, most patients with this listed allergy had reactions with characteristics that would qualify their penicillin allergy as low-risk of having a subsequent serious reaction (when considering initial reaction symptoms, time since initial reaction and if treatment was required). Of patients with penicillin allergy listed, it has been demonstrated that \>90% can tolerate penicillin after further evaluation, indicating a significant number of patients with an unnecessary penicillin allergy label.
Penicillin allergy delabeling is a practice commonly performed by allergists to test patients for safe removal of penicillin allergy from their medical records. The protocol of penicillin allergy delabeling has historically consisted of a skin test, followed by a two-step graded direct oral challenge, in which patients are given a smaller, then larger, oral dose of amoxicillin, a penicillin-containing medication. The patient is monitored closely throughout the process for reaction to penicillin and, if necessary, treatment is given for management of reaction symptoms. This method, though functional, takes time and resources to delabel patients.
As our understanding of penicillin drug allergy evolves, it may be possible to reduce the number of steps (and therefore resources) necessary to safely remove penicillin allergy labels. New data suggests that skin testing may not be a necessary step in penicillin allergy delabeling in a subset of low-risk patients. It has also been demonstrated in several studies that a single-dose direct oral challenge (rather than a two-step graded dose) is safe. A recent pilot study also showed that penicillin allergy delabeling can be safely performed in a primary care setting without the direct supervision of an allergist.
Per the authors' literature review, no prospective studies have directly compared the safety and efficacy of a single-dose versus a two-dose graded direct oral challenge. We propose a non-inferiority study in which patients classified as having a low-risk penicillin allergy are randomized into two groups and then receive either a single-dose or the traditional two-dose graded direct oral challenge to be able to evaluate these two treatment protocols in a side-by-side fashion. The results will contribute to our understanding of if a single-dose direct oral challenge can be safely used in place of the traditional two-dose graded direct oral challenge, thus reducing barriers for implementation in a primary care setting.
Patients with penicillin allergy that express interest through publicly posted recruitment materials will be screened to determine if they meet criteria for a "low-risk" allergy through the PEN-FAST screening tool, a recently developed, externally validated penicillin allergy risk assessment calculator. Those that meet the low-risk criteria and other eligibility criteria will be scheduled for an outpatient delabeling appointment. Participants will be randomly assigned in a double-blinded manner to receive either a two-dose graded direct oral challenge (DOC) with amoxicillin or a one-dose DOC placebo, followed by amoxicillin. Each group will receive the same cumulative dose of amoxicillin by the end of the challenge. Participants assigned to the two-dose graded DOC will be administered 62.5mg amoxicillin (25% of the full dose), followed by 187.5mg amoxicillin. Patients assigned to the one-dose DOC will be administered a placebo (Syrpalta or similar, a syrup used in drug compounding), followed by 250mg amoxicillin.
Doses will be given 30 minutes apart from one another. Both groups will be observed for a minimum of 1 hour after administration of the final dose of amoxicillin. Vital signs will be taken immediately before starting the trial, 30 minutes after administration of the first dose, and 60 minutes after administration of the second dose. If patients develop a reaction at any point in the trial, they will be treated according to the type and severity of their symptoms in an appropriate and standardized manner.
As both single-dose and graded two-dose challenges have been used in clinical practice to remove penicillin allergy labels in the past, if no reaction occurs, patients can have their penicillin allergy removed from their chart. Patients will be contacted around 5 days after the challenge to evaluate for any delayed reactions. If, at the 5-day phone call, patients have not had any other reactions suspected to be related to amoxicillin, their penicillin allergy label will be removed at that time. Patients will also be contacted around 6 months after the DOC to evaluate for any reactions to antibiotics received since successful delabeling. The two groups will then be compared to determine if the one-dose challenge is noninferior to the standard graded two-dose challenge (based upon the rate of successful delabeling without adverse reactions).
Currently, this study is approved as a single-site study only.
Penicillin allergy delabeling is a practice commonly performed by allergists to test patients for safe removal of penicillin allergy from their medical records. The protocol of penicillin allergy delabeling has historically consisted of a skin test, followed by a two-step graded direct oral challenge, in which patients are given a smaller, then larger, oral dose of amoxicillin, a penicillin-containing medication. The patient is monitored closely throughout the process for reaction to penicillin and, if necessary, treatment is given for management of reaction symptoms. This method, though functional, takes time and resources to delabel patients.
As our understanding of penicillin drug allergy evolves, it may be possible to reduce the number of steps (and therefore resources) necessary to safely remove penicillin allergy labels. New data suggests that skin testing may not be a necessary step in penicillin allergy delabeling in a subset of low-risk patients. It has also been demonstrated in several studies that a single-dose direct oral challenge (rather than a two-step graded dose) is safe. A recent pilot study also showed that penicillin allergy delabeling can be safely performed in a primary care setting without the direct supervision of an allergist.
Per the authors' literature review, no prospective studies have directly compared the safety and efficacy of a single-dose versus a two-dose graded direct oral challenge. We propose a non-inferiority study in which patients classified as having a low-risk penicillin allergy are randomized into two groups and then receive either a single-dose or the traditional two-dose graded direct oral challenge to be able to evaluate these two treatment protocols in a side-by-side fashion. The results will contribute to our understanding of if a single-dose direct oral challenge can be safely used in place of the traditional two-dose graded direct oral challenge, thus reducing barriers for implementation in a primary care setting.
Patients with penicillin allergy that express interest through publicly posted recruitment materials will be screened to determine if they meet criteria for a "low-risk" allergy through the PEN-FAST screening tool, a recently developed, externally validated penicillin allergy risk assessment calculator. Those that meet the low-risk criteria and other eligibility criteria will be scheduled for an outpatient delabeling appointment. Participants will be randomly assigned in a double-blinded manner to receive either a two-dose graded direct oral challenge (DOC) with amoxicillin or a one-dose DOC placebo, followed by amoxicillin. Each group will receive the same cumulative dose of amoxicillin by the end of the challenge. Participants assigned to the two-dose graded DOC will be administered 62.5mg amoxicillin (25% of the full dose), followed by 187.5mg amoxicillin. Patients assigned to the one-dose DOC will be administered a placebo (Syrpalta or similar, a syrup used in drug compounding), followed by 250mg amoxicillin.
Doses will be given 30 minutes apart from one another. Both groups will be observed for a minimum of 1 hour after administration of the final dose of amoxicillin. Vital signs will be taken immediately before starting the trial, 30 minutes after administration of the first dose, and 60 minutes after administration of the second dose. If patients develop a reaction at any point in the trial, they will be treated according to the type and severity of their symptoms in an appropriate and standardized manner.
As both single-dose and graded two-dose challenges have been used in clinical practice to remove penicillin allergy labels in the past, if no reaction occurs, patients can have their penicillin allergy removed from their chart. Patients will be contacted around 5 days after the challenge to evaluate for any delayed reactions. If, at the 5-day phone call, patients have not had any other reactions suspected to be related to amoxicillin, their penicillin allergy label will be removed at that time. Patients will also be contacted around 6 months after the DOC to evaluate for any reactions to antibiotics received since successful delabeling. The two groups will then be compared to determine if the one-dose challenge is noninferior to the standard graded two-dose challenge (based upon the rate of successful delabeling without adverse reactions).
Currently, this study is approved as a single-site study only.
Conditions
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Penicillin Allergy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
\- Low-risk penicillin allergic patients ("low-risk" determined by a PEN-FAST score of 2 or less) will be recruited. Clinically stable patients will be randomly assigned in a double-blinded manner to receive either a one-dose or graded two-dose direct oral challenge with amoxicillin in an outpatient setting. Those assigned to receive one dose of amoxicillin will receive a placebo in place of a second dose of amoxicillin. Both groups will receive the same cumulative dose of amoxicillin (250mg) by the end of the trial. Baseline vital signs will be obtained and tracked throughout the trial. Patients will also be monitored for development of signs of allergic reactions during the trial, with administration of appropriate treatment should the need arise.
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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One-dose group
Patients assigned to this group will receive a liquid placebo followed by full-dose liquid amoxicillin 250mg PO thirty minutes later.
Group Type
EXPERIMENTAL
Amoxicillin 250 MG
Intervention Type
DRUG
Liquid amoxicillin 250mg PO
Placebo
Intervention Type
DRUG
Given prior to amoxicillin 250mg in one-dose group
Graded, two-dose group
Patients assigned to this group will receive liquid amoxicillin (25% of 250mg dose), followed by liquid amoxicillin 187.5mg PO (75% of 250mg dose) thirty minutes later.
Group Type
ACTIVE_COMPARATOR
Amoxicillin 62.5mg
Intervention Type
DRUG
Given first in two-dose group, liquid amoxicillin 62.5mg PO
Amoxicillin 187.5mg
Intervention Type
DRUG
Given second in two-dose group, liquid amoxicillin 187.5mg PO
Interventions
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Amoxicillin 250 MG
Liquid amoxicillin 250mg PO
Intervention Type
DRUG
Placebo
Given prior to amoxicillin 250mg in one-dose group
Intervention Type
DRUG
Amoxicillin 62.5mg
Given first in two-dose group, liquid amoxicillin 62.5mg PO
Intervention Type
DRUG
Amoxicillin 187.5mg
Given second in two-dose group, liquid amoxicillin 187.5mg PO
Intervention Type
DRUG
Other Intervention Names
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One-dose group
Liquid placebo (Syrpalta or similar) for one-dose group
Two-dose group, dose 1 of 2
Two-dose group, dose 2 of 2
Eligibility Criteria
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Inclusion Criteria
* Expresses interest in participating by calling or filling out information form on study website
* Reports an allergy to one of the following medications: penicillin VK, penicillin G, amoxicillin, ampicillin, dicloxacillin, flucloxacillin, nafcillin, oxacillin, amoxicillin- clavulanate, ampicillin-sulbactam. Subjects with an unspecified penicillin allergy are also eligible to participate.
* Reports an allergy to one of the following medications: penicillin VK, penicillin G, amoxicillin, ampicillin, dicloxacillin, flucloxacillin, nafcillin, oxacillin, amoxicillin- clavulanate, ampicillin-sulbactam. Subjects with an unspecified penicillin allergy are also eligible to participate.
Exclusion Criteria
* Penicillin allergy deemed to be more than "low-risk" per PEN-FAST (score ≥ 3 points)
* History of acute kidney injury (acute interstitial nephritis), severe liver impairment (drug- induced liver injury), serum sickness, or isolated drug fever attributed to a penicillin- based antibiotic
* Anaphylaxis for any reason in the last year
* Cognitive impairment where a collateral history could not be obtained and/or patient does not have capacity to consent for themselves
* Pregnant (self-reported)
* Any illness or condition that would increase the risk of participation in the study, per the evaluating clinician's judgment
* Active treatment of or history of acute angle closure glaucoma
* On H1- or H2-blockers (i.e. diphenhydramine, hydroxyzine, chlorpheniramine, cetirizine, levocetirizine, loratadine, fexofenadine or famotidine, ranitidine, cimetidine, nizatidine, respectively) within 72 hours of initiating direct oral challenge (will be counseled to discontinue prior to testing)
* Actively receiving greater than stress dose steroid (hydrocortisone \>50mg four times a day or steroid equivalent)
* Actively receiving any antibiotic
* Relative contraindication: Patients on beta blockers and angiotensin converting enzyme inhibitors (ACE inhibitors) will have an open dialog with the study team regarding the risks and benefits of testing a low-risk penicillin allergy patient. A joint decision will be made based on the patient's preference and the physician's comfort level.
* History of acute kidney injury (acute interstitial nephritis), severe liver impairment (drug- induced liver injury), serum sickness, or isolated drug fever attributed to a penicillin- based antibiotic
* Anaphylaxis for any reason in the last year
* Cognitive impairment where a collateral history could not be obtained and/or patient does not have capacity to consent for themselves
* Pregnant (self-reported)
* Any illness or condition that would increase the risk of participation in the study, per the evaluating clinician's judgment
* Active treatment of or history of acute angle closure glaucoma
* On H1- or H2-blockers (i.e. diphenhydramine, hydroxyzine, chlorpheniramine, cetirizine, levocetirizine, loratadine, fexofenadine or famotidine, ranitidine, cimetidine, nizatidine, respectively) within 72 hours of initiating direct oral challenge (will be counseled to discontinue prior to testing)
* Actively receiving greater than stress dose steroid (hydrocortisone \>50mg four times a day or steroid equivalent)
* Actively receiving any antibiotic
* Relative contraindication: Patients on beta blockers and angiotensin converting enzyme inhibitors (ACE inhibitors) will have an open dialog with the study team regarding the risks and benefits of testing a low-risk penicillin allergy patient. A joint decision will be made based on the patient's preference and the physician's comfort level.
Minimum Eligible Age
18 Years
Maximum Eligible Age
89 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Texas Tech University Health Sciences Center
OTHER
Sponsor Role
collaborator
James Tarbox, MD
OTHER
Sponsor Role
lead
Responsible Party
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James Tarbox, MD
Associate Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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James A Tarbox, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Tech University Health Sciences Center
Locations
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Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Blumenthal KG, Peter JG, Trubiano JA, Phillips EJ. Antibiotic allergy. Lancet. 2019 Jan 12;393(10167):183-198. doi: 10.1016/S0140-6736(18)32218-9. Epub 2018 Dec 14.
Reference Type
BACKGROUND
Trubiano JA, Vogrin S, Chua KYL, Bourke J, Yun J, Douglas A, Stone CA, Yu R, Groenendijk L, Holmes NE, Phillips EJ. Development and Validation of a Penicillin Allergy Clinical Decision Rule. JAMA Intern Med. 2020 May 1;180(5):745-752. doi: 10.1001/jamainternmed.2020.0403.
Reference Type
BACKGROUND
Khan DA, Banerji A, Blumenthal KG, Phillips EJ, Solensky R, White AA, Bernstein JA, Chu DK, Ellis AK, Golden DBK, Greenhawt MJ, Horner CC, Ledford D, Lieberman JA, Oppenheimer J, Rank MA, Shaker MS, Stukus DR, Wallace D, Wang J; Chief Editor(s):; Khan DA, Golden DBK, Shaker M, Stukus DR; Workgroup Contributors:; Khan DA, Banerji A, Blumenthal KG, Phillips EJ, Solensky R, White AA; Joint Task Force on Practice Parameters Reviewers:; Bernstein JA, Chu DK, Ellis AK, Golden DBK, Greenhawt MJ, Horner CC, Ledford D, Lieberman JA, Oppenheimer J, Rank MA, Shaker MS, Stukus DR, Wallace D, Wang J. Drug allergy: A 2022 practice parameter update. J Allergy Clin Immunol. 2022 Dec;150(6):1333-1393. doi: 10.1016/j.jaci.2022.08.028. Epub 2022 Sep 17. No abstract available.
Reference Type
BACKGROUND
Iammatteo M, Lezmi G, Confino-Cohen R, Tucker M, Ben-Shoshan M, Caubet JC. Direct Challenges for the Evaluation of Beta-Lactam Allergy: Evidence and Conditions for Not Performing Skin Testing. J Allergy Clin Immunol Pract. 2021 Aug;9(8):2947-2956. doi: 10.1016/j.jaip.2021.04.073.
Reference Type
BACKGROUND
Iammatteo M, Alvarez Arango S, Ferastraoaru D, Akbar N, Lee AY, Cohen HW, Jerschow E. Safety and Outcomes of Oral Graded Challenges to Amoxicillin without Prior Skin Testing. J Allergy Clin Immunol Pract. 2019 Jan;7(1):236-243. doi: 10.1016/j.jaip.2018.05.008. Epub 2018 May 23.
Reference Type
BACKGROUND
Copaescu AM, Vogrin S, James F, Chua KYL, Rose MT, De Luca J, Waldron J, Awad A, Godsell J, Mitri E, Lambros B, Douglas A, Youcef Khoudja R, Isabwe GAC, Genest G, Fein M, Radojicic C, Collier A, Lugar P, Stone C, Ben-Shoshan M, Turner NA, Holmes NE, Phillips EJ, Trubiano JA. Efficacy of a Clinical Decision Rule to Enable Direct Oral Challenge in Patients With Low-Risk Penicillin Allergy: The PALACE Randomized Clinical Trial. JAMA Intern Med. 2023 Sep 1;183(9):944-952. doi: 10.1001/jamainternmed.2023.2986.
Reference Type
BACKGROUND
Wang LA, Patel K, Kuruvilla ME, Shih J. Direct amoxicillin challenge without preliminary skin testing for pediatric patients with penicillin allergy labels. Ann Allergy Asthma Immunol. 2020 Aug;125(2):226-228. doi: 10.1016/j.anai.2020.05.004. Epub 2020 May 11. No abstract available.
Reference Type
BACKGROUND
Lin L, Nagtegaal JE, Buijtels PCAM, Jong E. Antimicrobial stewardship intervention: optimizing antibiotic treatment in hospitalized patients with reported antibiotic allergy. J Hosp Infect. 2020 Feb;104(2):137-143. doi: 10.1016/j.jhin.2019.10.007. Epub 2019 Oct 13.
Reference Type
BACKGROUND
Trubiano JA, Smibert O, Douglas A, Devchand M, Lambros B, Holmes NE, Chua KY, Phillips EJ, Slavin MA. The Safety and Efficacy of an Oral Penicillin Challenge Program in Cancer Patients: A Multicenter Pilot Study. Open Forum Infect Dis. 2018 Nov 17;5(12):ofy306. doi: 10.1093/ofid/ofy306. eCollection 2018 Dec.
Reference Type
BACKGROUND
Chua KYL, Vogrin S, Bury S, Douglas A, Holmes NE, Tan N, Brusco NK, Hall R, Lambros B, Lean J, Stevenson W, Devchand M, Garrett K, Thursky K, Grayson ML, Slavin MA, Phillips EJ, Trubiano JA. The Penicillin Allergy Delabeling Program: A Multicenter Whole-of-Hospital Health Services Intervention and Comparative Effectiveness Study. Clin Infect Dis. 2021 Aug 2;73(3):487-496. doi: 10.1093/cid/ciaa653.
Reference Type
BACKGROUND
Tucker MH, Lomas CM, Ramchandar N, Waldram JD. Amoxicillin challenge without penicillin skin testing in evaluation of penicillin allergy in a cohort of Marine recruits. J Allergy Clin Immunol Pract. 2017 May-Jun;5(3):813-815. doi: 10.1016/j.jaip.2017.01.023. Epub 2017 Mar 21. No abstract available.
Reference Type
BACKGROUND
Kuruvilla M, Shih J, Patel K, Scanlon N. Direct oral amoxicillin challenge without preliminary skin testing in adult patients with allergy and at low risk with reported penicillin allergy. Allergy Asthma Proc. 2019 Jan 1;40(1):57-61. doi: 10.2500/aap.2019.40.4184.
Reference Type
BACKGROUND
Chow TG, Patel G, Mohammed M, Johnson D, Khan DA. Delabeling penicillin allergy in a pediatric primary care clinic. Ann Allergy Asthma Immunol. 2023 May;130(5):667-669. doi: 10.1016/j.anai.2023.01.034. Epub 2023 Feb 2. No abstract available.
Reference Type
BACKGROUND
Livirya S, Pithie A, Chua I, Hamilton N, Doogue M, Isenman H. Oral amoxicillin challenge for low-risk penicillin allergic patients. Intern Med J. 2022 Feb;52(2):295-300. doi: 10.1111/imj.14978. Epub 2022 Jan 12.
Reference Type
BACKGROUND
Related Links
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https://delabelingpenicillin.wixsite.com/penicillin-de-labeli
Recruiting Website
Other Identifiers
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IRB-FY2024-61
Identifier Type: -
Identifier Source: org_study_id
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