Inpatient Penicillin Delabeling for Low-Risk Patients

Phase 4

• Conditions: Drug Allergy; Penicillin
• Interventions: Procedure: Direct Oral Challenge

• Registration Number: NCT06414694
• Lead Sponsor: University of Tennessee

Brief Summary

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.

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 Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2024-04-25
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-09
• Last Update Submitted: 2024-05-09
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

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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,

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Direct Challenge	Direct Oral 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.

Primary Outcome Measures

Name	Time	Method
Direct Oral Challenge	2 hours	Pass or Failure of direct oral challenge

Secondary Outcome Measures

Name	Time	Method
Follow-up at 48	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.
Follow-up at 6 months	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.

Trial Locations

Locations (1)

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States