Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
NCT Number: NCT03702283
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)
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37232, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
Time frame: Hospital discharge at approximately 7 days after ICU transfer
The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.
Time frame: Hospital discharge at approximately 7 days after ICU transfer
The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge
Time frame: Hospital discharge at approximately 7 days after ICU transfer
The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events
Time frame: Hospital discharge at approximately 7 days after ICU transfer
The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.
Time frame: 2 years observation
The number of changes or new starts of penicillin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event
Vanderbilt University Medical Center
Other
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