The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal

Penicillin Allergy Clinical Trial

Official title:

The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702270
• Other study ID #: 181734
• Status: Completed
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: May 11, 2023

Study information

• Verified date: July 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. There is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. Previous studies have utilized quasi-experimental designs. Test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. Our objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a randomized controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2040
• Est. completion date: May 11, 2023
• Est. primary completion date: December 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• VUMC patients age 18 or older with a penicillin allergy reported in their chart, and are medically stable, currently admitted to stepdown unit or regular floor bed.

Exclusion Criteria:

• Patients with a penicillin allergy reported in their chart, but who are currently medically unstable.

• Pregnant patients

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Hypersensitivity
• Penicillin Allergy

Intervention

Other:
• Penicillin Allergic Risk Stratification Best Practice Alert
Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Vanderbilt Institute for Clinical and Translational Research (Learning Healthcare System)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penicillin allergy label removal	The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.	Hospital discharge at approximately 4 days after admission
Primary	Patients with low risk penicillin allergy label who underwent amoxicillin challenge	The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge	Hospital discharge at approximately 4 days after admission
Secondary	Adverse events (in particular, reported allergic events)	The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events	Hospital discharge at approximately 4 days after admission
Secondary	Communication about penicillin allergy in discharge summary	The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.	Hospital discharge at approximately 4 days after admission
Secondary	Antibiotic utilization by patients	The number of changes or new starts of penicillin or cephalosporin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"	Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Secondary	Durability of penicillin allergy label removal	The proportion of penicillin allergic patients whose penicillin allergy labels were removed at discharge whose labels are not reentered into the chart.	Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up
Secondary	Tolerance of amoxicillin challenge	Any adverse events reported in association with amoxicillin challenge	Within 24 hours of the amoxicillin challenge
Secondary	Uptake of the risk stratification tool	Determined by whether patients with a penicillin allergy label received a risk assessment	Hospital discharge at approximately 4 days after admission
Secondary	Time to penicillin allergy label return	For those patients who underwent a penicillin allergy label removal and it returns, we will compare the date the allergy label returned with the date it was removed	From 3-18 months of follow up