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

Part of paid clinical trials in Lubbock, Texas.

Sponsor
James Tarbox, MD
Study ID
NCT06303128
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Penicillin Allergy

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Amoxicillin 250 MG — DRUG
    Liquid amoxicillin 250mg PO
  • Placebo — DRUG
    Given prior to amoxicillin 250mg in one-dose group
  • Amoxicillin 62.5mg — DRUG
    Given first in two-dose group, liquid amoxicillin 62.5mg PO
  • Amoxicillin 187.5mg — DRUG
    Given second in two-dose group, liquid amoxicillin 187.5mg PO

Study Details

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.

Key Dates

Start date
Feb 3, 2024
Status verified
Apr 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
380 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: One-dose group
    Patients assigned to this group will receive a liquid placebo followed by full-dose liquid amoxicillin 250mg PO thirty minutes later.
  • Active Comparator: Graded, two-dose group
    Patients assigned to this group will receive liquid amoxicillin (25% of 250mg dose), followed by liquid amoxicillin 187.5mg PO (75% of 250mg dose) thirty minutes later.

Primary Outcome Measure

Proportion of successfully "delabeled" subjects in one-dose versus two-dose groups [ Time Frame: 5 days (at time of first follow up phone call) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Tech University Health Sciences CenterLubbockTexas79430
Study Coordinator
[email protected]
806-543-8994
Joshua A Peterson, MD
[email protected]
Joshua A Peterson, MD (SUB_INVESTIGATOR)
Nicole Welch, MD (SUB_INVESTIGATOR)
KaKa L Adams, MD (SUB_INVESTIGATOR)
Sierra Sullivan, MD (SUB_INVESTIGATOR)
Jacob Nichols, MD (PRINCIPAL_INVESTIGATOR)
James A Tarbox, MD (PRINCIPAL_INVESTIGATOR)
Watsachon Pangkanon, MD (SUB_INVESTIGATOR)
Nattanicha Chaisrimaneepan, MD (SUB_INVESTIGATOR)
Safa Mohamed, MD (SUB_INVESTIGATOR)
Maireigh McCullough, MD (SUB_INVESTIGATOR)
Diego Olavarria Bernal, MD (SUB_INVESTIGATOR)
Miriam Paz Sierra, MD (SUB_INVESTIGATOR)

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By research site
Texas Tech University Health Sciences Center· Lubbock, TX

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