Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge
Recruiting
Phase 3
Interventional Study
Penicillin Allergy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 89
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 380 (estimated)
- Sponsor
- James Tarbox, MD · Other
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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) …
Trial Locations
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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- cla…
Contacts