Inpatient Penicillin Delabeling for Low-Risk Patients

Drug Allergy Clinical Trial

Official title:

Inpatient Penicillin Delabeling for Low-Risk Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06414694
• Other study ID #: 23-09373-FB
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: September 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: September 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 30 Years

Eligibility

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,

Related Conditions & MeSH terms

• Drug Allergy
• Drug Hypersensitivity

Intervention

Procedure:
• Direct Oral Challenge
Direct oral challenge to penicillin at a goal dose of 45 mg/kg given in a 10%/90% dose

Locations

Country	Name	City	State
United States	University of Tennessee Health Science Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Direct Oral Challenge	Pass or Failure of direct oral challenge	2 hours
Secondary	Follow-up at 48	Follow-up phone call to assess adverse reaction by 48 hours. Data to be collected by screening questionnaire to assess for reactions such as fever, rash, manufacturer labeled adverse side effects.	48 hours
Secondary	Follow-up at 6 months	Follow-up phone call to assess subsequent tolerance or reaction of penicillin based antibiotic if prescribed in this time period. Data to be collected by screening questionnaire.	6 months