Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting

Penicillin Allergy Clinical Trial

Official title:

Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702283
• Other study ID #: 181734 -Pilot
• Status: Completed
• Phase: N/A
• Start date: March 31, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: January 2022
• 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. The investigators objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a single arm intervention pilot trial in the ICU setting, which will pave the way for a future stepped wedge randomized control trial (stepped wedge trial entered separately in clinical trials.gov as NCT03702270)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

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 7 days after ICU transfer
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 7 days after ICU transfer
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 7 days after ICU transfer
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 7 days after ICU transfer
Secondary	Antibiotic Utilization by Patients	The number of changes or new starts of penicillin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event	2 years observation