CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 240 enrolled
Drug / intervention
Penicillin Allergic Risk Stratification Best Practice Alertother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03702283
NCT03702283N/ACompleted

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

Vanderbilt University Medical Center·interventional·Posted Oct 11, 2018·Updated May 13, 2022

In Brief

A clinical study evaluating Penicillin Allergic Risk Stratification Best Practice Alert for Penicillin Allergy. Completed, enrolled 240 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 11, 2018
Enrollment StartMar 31, 2019
Primary CompletionMar 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 7.7 years ago

Interventions

Penicillin Allergic Risk Stratification Best Practice Alertother

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