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Clinical trialNCT06303128RecruitingPhase 3Interventional

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

SponsorJames Tarbox, MDEnrollment380Penicillin Allergy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Texas Tech University Health Sciences Center

    Lubbock, Texas, United States

    Diego Olavarria Bernal, MDJacob Nichols, MDJames A Tarbox, MDJoshua A Peterson, MDKaKa L Adams, MDMaireigh McCullough, MDMiriam Paz Sierra, MDNattanicha Chaisrimaneepan, MDNicole Welch, MDSafa Mohamed, MDSierra Sullivan, MDWatsachon Pangkanon, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Amoxicillin 187.5mgAmoxicillin →Amoxicillin 62.5mgPlacebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
3 Feb 2024
Primary completion
31 Jul 2026
Completion
31 Dec 2026
Last update posted
1 May 2025
Registered enrollment
380
Registry id
NCT06303128

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.