NCT06414694

Inpatient Penicillin Delabeling for Low-Risk Patients

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Tennessee · Academic / Other
• Sex: All
• Age: 2 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Penicillin
• Drug Allergy

Interventions

Type	Name	Description
PROCEDURE	Direct Oral Challenge	Direct oral challenge to penicillin at a goal dose of 45 mg/kg given in a 10%/90% dose

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-06-30
• Completion: 2025-09-30
• First posted: 2024-05-16
• Last updated: 2024-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study