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

NCT06303128 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2025-05-01

No results posted yet for this study

Summary

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.

Conditions

  • Penicillin Allergy

Interventions

DRUG

Amoxicillin 250 MG

Liquid amoxicillin 250mg PO

DRUG

Placebo

Given prior to amoxicillin 250mg in one-dose group

DRUG

Amoxicillin 62.5mg

Given first in two-dose group, liquid amoxicillin 62.5mg PO

DRUG

Amoxicillin 187.5mg

Given second in two-dose group, liquid amoxicillin 187.5mg PO

Sponsors & Collaborators

  • Texas Tech University Health Sciences Center

    collaborator OTHER

  • James Tarbox, MD

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-03
Primary Completion
2026-07-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06303128 on ClinicalTrials.gov