Testing a single versus double dose of amoxicillin for penicillin allergy delabeling
Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge
This study tests whether giving one dose of amoxicillin is just as safe and effective as giving two doses for adults who have been labeled as penicillin-allergic but are considered low-risk.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Texas Tech University Health Sciences Center Academic / other |
| Locations | 1 site (Lubbock, Texas) |
| Trial ID | NCT06303128 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with a reported low-risk penicillin allergy who are interested in participating.
Not a fit: Patients with a high-risk penicillin allergy or those who have experienced anaphylaxis in the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could simplify the process of removing unnecessary penicillin allergy labels, allowing more patients to access effective antibiotic treatments.
How similar studies have performed: Other studies have indicated that a significant majority of patients can tolerate penicillin after evaluation, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lubbock, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.