Inpatient Penicillin Delabeling for Low-Risk Patients

May 9, 2024 updated by: University of Tennessee
This study seeks to enroll patients admitted to a children's hospital with identified penicillin allergy. A screening checklist is performed to identify patients with very low or low risk histories of penicillin allergy to offer direct oral challenges to the antibiotic class to de-label patient's with drug allergies.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This is a pilot study looking to utilize a novel criterion to identify low risk penicillin allergies for patients admitted to a children's hospital to evaluate safety and efficacy of direct oral challenges to patients with very low or low risk histories as identified in novel criterion.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients >2 years
  • Patients identified via EMR as having a penicillin, amoxicillin, amoxicillin/clavulanic acid allergy

Exclusion Criteria:

  • Female patients aged >8 years of age
  • Patients with hemodynamic instability
  • Patients identified with moderate or high risk histories per protocol
  • Patients currently taking oral antihistamines in 48 hours prior to direct challenge
  • Patients currently taking oral steroids in 48 hours prior to direct challenge
  • Patients currently receiving medications for nausea, shortness of breath,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Direct Challenge
Patients who met enrollment criteria proceed to direct oral challenge with penicillin with one hour observation, 48 hour phone call, six month follow-up.
Procedure: Direct Oral Challenge
Direct oral challenge to penicillin at a goal dose of 45 mg/kg given in a 10%/90% dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct Oral Challenge
Time Frame: 2 hours
Pass or Failure of direct oral challenge
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up at 48
Time Frame: 48 hours
Follow-up phone call to assess adverse reaction by 48 hours. Data to be collected by screening questionnaire to assess for reactions such as fever, rash, manufacturer labeled adverse side effects.
48 hours
Follow-up at 6 months
Time Frame: 6 months
Follow-up phone call to assess subsequent tolerance or reaction of penicillin based antibiotic if prescribed in this time period. Data to be collected by screening questionnaire.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-09373-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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