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

ConditionPenicillin Allergy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-89
SponsorJames Tarbox, MD

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) 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: One-dose groupExperimental treatment 2 interventions
Group B: Graded, two-dose groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of successfully "delabeled" subjects in one-dose versus two-dose groups

Percentage of subjects that successfully complete either the one-dose or graded two-dose direct oral challenge with amoxicillin without adverse reactions during the challenge, as determined by no reaction reported at first follow up phone call.

Time frame
5 days (at time of first follow up phone call)

Secondary outcomes

1

Analysis of adverse reactions

Percentage of subjects that report adverse reactions during direct oral challenge and at 5-day follow-up phone call, including type of reaction, timing, severity, treatment required (if any), and classification of degree of causality.

Time frame
2 hours (during direct oral challenge) and 5 days (at time of first follow up phone call)
2

Analysis of medical and allergic history

For further stratification of primary outcome, other medical and allergic history items including: reported penicillin allergy label, history of cephalosporin allergy, PEN-FAST score, time (in years) since index reaction, time (in hours) between administration of medication and index reaction, treatment required for index reaction, antibiotics tolerated since index reaction, history of other atopic conditions, and use of beta blockers/ACE inhibitors.

Time frame
Reported at time of direct oral challenge
3

Validation of penicillin allergy delabeling

Data from 6-month follow up phone call including: percentage of successfully delabeled patients able to tolerate penicillin-derived antibiotics since DOC and any associated reactions, percentage of patients confident in taking a penicillin derivative should it be required in the future.

Time frame
6 months
4

Analysis of demographic data

For further stratification of primary outcome, demographic data, including age, gender, race/ethnicity, urban vs. rural and other measures of socioeconomic status. This will allow us to analyze differences in reaction rates between different groups, as well as psychological differences between groups when considering patient confidence in their allergy label being removed.

Time frame
Reported at time of direct oral challenge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

James Tarbox, MD

Lead sponsor

Texas Tech University Health Sciences Center

Sponsor institution

Texas Tech University Health Sciences Center

Collaborator

Source ClinicalTrials.gov
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