RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-03
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06303128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Expresses interest in participating by calling or filling out information form on study website
  2. * 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.
  1. * Penicillin allergy deemed to be more than "low-risk" per PEN-FAST (score ≥ 3 points)
  2. * 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
  3. * Anaphylaxis for any reason in the last year
  4. * Cognitive impairment where a collateral history could not be obtained and/or patient does not have capacity to consent for themselves
  5. * Pregnant (self-reported)
  6. * Any illness or condition that would increase the risk of participation in the study, per the evaluating clinician's judgment
  7. * Active treatment of or history of acute angle closure glaucoma
  8. * 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)
  9. * Actively receiving greater than stress dose steroid (hydrocortisone \>50mg four times a day or steroid equivalent)
  10. * Actively receiving any antibiotic
  11. * 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.

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
806-543-8994
clinicalresearch@ttuhsc.edu
Joshua A Peterson, MD
CONTACT
josh.peterson@ttuhsc.edu

Principal Investigator

James A Tarbox, MD
PRINCIPAL_INVESTIGATOR
Texas Tech University Health Sciences Center

Study Locations (Sites)

Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
United States

Collaborators and Investigators

Sponsor: James Tarbox, MD

  • James A Tarbox, MD, PRINCIPAL_INVESTIGATOR, Texas Tech University Health Sciences Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-03
Study Completion Date2025-05

Study Record Updates

Study Start Date2024-02-03
Study Completion Date2025-05

Terms related to this study

Keywords Provided by Researchers

  • low-risk allergy
  • amoxicillin
  • drug allergy
  • direct oral challenge

Additional Relevant MeSH Terms

  • Penicillin Allergy