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Completed

NCT Number: NCT03702270

The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal

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.

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Key information

Conditions

Penicillin Allergy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Pregnant patients

Treatment and study plan

Penicillin Allergic Risk Stratification Best Practice Alert

Other

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

Primary outcomes

  1. Penicillin Allergy Label Removal

    Time frame: Hospital discharge at approximately 4 days after admission

    The percentage of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.

Secondary outcomes

  1. Adverse Events (in Particular, Reported Allergic Events)

    Time frame: Hospital discharge at approximately 4 days after admission

    The percentage of penicillin allergic patients challenged with amoxicillin who reported adverse events

  2. Communication About Penicillin Allergy in Discharge Summary

    Time frame: Hospital discharge at approximately 4 days after admission

    The percentage of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.

  3. Antibiotic Utilization by Patients

    Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up

    The number of changes or new starts of penicillin or cephalosporin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"

  4. Durability of Penicillin Allergy Label Removal

    Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up

    The percentage of penicillin allergic patients whose penicillin allergy labels were removed at discharge whose labels are not reentered into the chart.

  5. Receipt of Risk Stratification Tool Assessment

    Time frame: Hospital discharge at approximately 4 days after admission

    Number of patients with a penicillin allergy label who received a risk assessment.

  6. Time to Penicillin Allergy Label Return

    Time frame: From 3-18 months of follow up

    For those patients who underwent a penicillin allergy label removal and it returns, we will compare the date the allergy label returned with the date it was removed

  7. Penicillin Utilization by Patients

    Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up

    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, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"

  8. Cephalosporin Utilization by Patients

    Time frame: Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up

    The number of changes or new starts of cephalosporin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization"

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Oct 11, 2018
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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