Inpatient Penicillin Delabeling for Low-Risk Patients

University of Tennessee

Status and phase: Invitation-only; Phase 4

Conditions: Penicillin; Drug Allergy

Treatments: Procedure: Direct Oral Challenge

Study type: Interventional

Funder types: Other

Identifiers

NCT06414694

23-09373-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 2 to 30 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Direct Challenge

Experimental group

Description:

Patients who met enrollment criteria proceed to direct oral challenge with penicillin with one hour observation, 48 hour phone call, six month follow-up.

Treatment:

Procedure: Direct Oral Challenge