By InvitationPhase 4

Inpatient Penicillin Delabeling for Low-Risk Patients

United States25 participantsStarted 2023-09-01

Plain-language 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.

Who can participate

Age range2 Years – 30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,

What they're measuring

Direct Oral Challenge

Timeframe: 2 hours

Trial details

NCT IDNCT06414694

SponsorUniversity of Tennessee

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

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