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N/A N=205 Treatment

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

Penicillin Allergy

Enrolled (actual)
205
Serious AEs
0.5%
Results posted
May 2022
Primary outcome: Primary: Penicillin Allergy Label Removal — 201 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Penicillin Allergic Risk Stratification Best Practice Alert (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Vanderbilt University Medical Center
Primary completion
Mar 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Penicillin Allergy Label Removal
201
PRIMARY
Patients With Low Risk Penicillin Allergy Label Who Underwent Amoxicillin Challenge
205
SECONDARY
Adverse Events (in Particular, Reported Allergic Events)
1
SECONDARY
Communication About Penicillin Allergy in Discharge Summary
202
SECONDARY
Antibiotic Utilization by Patients
59

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03702283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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