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

NCT03702283 | Completed Results DMC

• 1 other identifier: 181734 -Pilot
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Penicillin Allergy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Adverse Events (in Particular, Reported Allergic Events)

  Hospital discharge at approximately 7 days after ICU transfer

• Communication About Penicillin Allergy in Discharge Summary

  Hospital discharge at approximately 7 days after ICU transfer

• Antibiotic Utilization by Patients

  2 years observation

Study Arms (1)

Penicillin Allergic ICU Patients

EXPERIMENTAL

The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.

Other: Penicillin Allergic Risk Stratification Best Practice Alert

Interventions

Penicillin Allergic Risk Stratification Best Practice Alert OTHER

Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.

Penicillin Allergic ICU Patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Koo G, Stollings JL, Lindsell C, Dear ML, Kripalani S, Nelson GE, McCoy AB, Rice TW, Phillips EJ, Stone CA Jr; Vanderbilt University Medical Center Learning Healthcare System. Low-risk penicillin allergy delabeling through a direct oral challenge in immunocompromised and/or multiple drug allergy labeled patients in a critical care setting. J Allergy Clin Immunol Pract. 2022 Jun;10(6):1660-1663.e2. doi: 10.1016/j.jaip.2022.01.041. Epub 2022 Feb 5. No abstract available.

  PMID: 35131513 DERIVED

Results Point of Contact

• Title: Cosby A Stone, Jr. MD, MPH
• Organization: VANDERBILT UNIVERSITY MEDICAL CENTER

Cosby.a.stone@vumc.org

6153223412

Study Officials

• Cosby A Stone, Jr., MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Chris Lindsell, PhD

  Vanderbilt University Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 11, 2018
• Study Start: March 31, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: May 13, 2022
• Results First Posted: May 13, 2022

Record last verified: 2022-01

Locations

US (1)