Clinical trial NCT03702283: Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting
Official title: Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Penicillin Allergy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Penicillin Allergy Label Removal
timeFrame: Hospital discharge at approximately 7 days after ICU transfer
measure: Patients With Low Risk Penicillin Allergy Label Who Underwent Amoxicillin Challenge
timeFrame: Hospital discharge at approximately 7 days after ICU transfer
Secondary outcomes:
measure: Adverse Events (in Particular, Reported Allergic Events)
timeFrame: Hospital discharge at approximately 7 days after ICU transfer
measure: Communication About Penicillin Allergy in Discharge Summary
timeFrame: Hospital discharge at approximately 7 days after ICU transfer
measure: Antibiotic Utilization by Patients
timeFrame: 2 years observation
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Cosby A Stone, Jr., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Chris Lindsell, PhD
role: STUDY_CHAIR
References:
citation: 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.