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Inpatient Penicillin Delabeling for Low-Risk Patients

NCT06414694 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-05-16

No results posted yet for this study

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.

Conditions

  • Penicillin
  • Drug Allergy

Interventions

PROCEDURE

Direct Oral Challenge

Direct oral challenge to penicillin at a goal dose of 45 mg/kg given in a 10%/90% dose

Sponsors & Collaborators

  • University of Tennessee

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-06-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06414694 on ClinicalTrials.gov