Penicillin Delabeling for Antibiotic Allergy

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Tennessee

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for patients admitted to a children's hospital who have been labeled with a penicillin allergy. It specifically seeks those considered at very low or low risk of having an actual allergy, based on a screening checklist.

Inclusion Criteria

I am older than 2 years.

Patients identified via EMR as having a penicillin, amoxicillin, amoxicillin/clavulanic acid allergy

Exclusion Criteria

I am a female older than 8 years.

Patients with hemodynamic instability

Patients identified with moderate or high risk histories per protocol

Treatment Details

Interventions

• Direct Oral Challenge (Anti-biotic)

Trial Overview The study involves giving these low-risk patients a direct oral challenge with penicillin-based antibiotics to see if they can safely remove the 'allergic' label from their medical records.

Participant Groups

Group I: Direct Challenge Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials

202

Recruited

146,000+