Testing a single versus double dose of amoxicillin for penicillin allergy delabeling

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine whether a one-dose oral challenge with amoxicillin is as safe and effective as a two-dose challenge for adults previously labeled as penicillin-allergic but considered low-risk. Participants will receive either one or two doses of amoxicillin in a controlled environment, where they will be monitored for allergic reactions. The study seeks to streamline the delabeling process, potentially reducing the time and resources required for patients to safely remove unnecessary penicillin allergy labels from their medical records.

Why it matters

Who can join: the full rules

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.

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.

Where it's running

• Texas Tech University Health Sciences Center
  Lubbock, Texas, United States Recruiting

Study contacts

• Principal investigator: James A Tarbox, MD — Texas Tech University Health Sciences Center
• Study coordinator: Study Coordinator
• Email: clinicalresearch@ttuhsc.edu
• Phone: 806-543-8994

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nurse-and-allergist provocation pathway for penicillin allergy delabelling (PANDA)

  This project will try a nurse-and-allergist team approach to remove incorrect penicillin allergy labels in patients treated at participating hospitals, and compare it to the usual allergist-only pathway.

  Recruiting at 4 sites The University of Hong Kong · Hong Kong and 3 other locations · NCT07127835

• Testing for safe removal of penicillin allergy labels

  This study is testing if a new way to check if people with low-risk penicillin allergies can safely take penicillin without needing skin tests.

  Recruiting at 2 sites University Hospital Heidelberg · Heidelberg, Baden-Wurttemberg and 1 other locations · NCT06755281

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.