Inpatient Penicillin Delabeling for Low-Risk Patients

Status unconfirmed · Phase 4

Conditions studied: Penicillin, Drug Allergy

In brief

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.

Key facts

Study ID

NCT06414694

Run by

University of Tennessee

People needed

25

Starts

2023-09-01

Expected to finish

2025-09-30

Last updated by the study team

2024-05-16

Who can join

Age: 2 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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,

Where it is running

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

Full record on ClinicalTrials.gov

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