The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 3/30/2019 |
| Start Date: | July 2019 |
| End Date: | July 2021 |
| Contact: | Cosby Stone, MD, MPH |
| Email: | cosby.a.stone@vumc.org |
| Phone: | 615-322-3412 |
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. Our 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.
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. Our 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 stepdown unit or regular floor bed.
Exclusion Criteria:
- Patients with a penicillin allergy reported in their chart, but who are currently
medically unstable.
- Patients whose primary care is not at Vanderbilt.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials
