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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-89
SponsorJames Tarbox, MD

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Amoxicillin 250 MG
  • Placebo
  • Amoxicillin 62.5mg
  • Amoxicillin 187.5mg

Treatment groups

380 Participants
are divided into 2 treatment groups

Sponsors and collaborators

James Tarbox, MD

Lead sponsor

Texas Tech University Health Sciences Center

Sponsor institution

Texas Tech University Health Sciences Center

Collaborator