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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03702283
Other study ID # 181734 -Pilot
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 31, 2019
Est. completion date March 31, 2021

Study information

Verified date January 2022
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design


Intervention

Other:
Penicillin Allergic Risk Stratification Best Practice Alert
Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Medical Center Vanderbilt Institute for Clinical and Translational Research (Learning Healthcare System)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Penicillin Allergy Label Removal The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section. Hospital discharge at approximately 7 days after ICU transfer
Primary Patients With Low Risk Penicillin Allergy Label Who Underwent Amoxicillin Challenge The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge Hospital discharge at approximately 7 days after ICU transfer
Secondary Adverse Events (in Particular, Reported Allergic Events) The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events Hospital discharge at approximately 7 days after ICU transfer
Secondary Communication About Penicillin Allergy in Discharge Summary The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge. Hospital discharge at approximately 7 days after ICU transfer
Secondary Antibiotic Utilization by Patients 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 2 years observation
See also
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