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



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 99
Updated:3/30/2019
Start Date:March 26, 2019
End Date:August 2019
Contact:Cosby A Stone, MD, MPH
Email:cosby.a.stone@vumc.org
Phone:615-322-3412

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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 randomized controlled trial.


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.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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mi
from
Nashville, TN
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