Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge

Launched by JAMES TARBOX, MD · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is examining whether giving a single dose of amoxicillin, a common penicillin-based antibiotic, is as safe and effective as giving two doses when testing if adults can safely have their penicillin allergy label removed. The study is focused on patients who have been identified as having a low-risk penicillin allergy, meaning they are less likely to have a serious allergic reaction. Participants will receive either one or two doses of amoxicillin in a controlled environment, where they will be closely monitored for any allergic reactions.

To be eligible for this trial, participants should be adults who have reported an allergy to certain penicillin medications, such as amoxicillin or penicillin G. However, those with a more serious allergy risk, recent severe allergic reactions, or certain health conditions may not qualify. If you join the study, you can expect to be carefully observed during the medication administration to ensure your safety. This trial is important because it could help determine safer options for patients who are labeled as penicillin-allergic, potentially allowing them to receive necessary antibiotics without fear of an allergic reaction.

Gender

ALL

Eligibility criteria

• 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.