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NCT03702283 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
NA
Development phase
240
Enrollment target

NCT03702283: Completed NA study, sponsored by Vanderbilt University Medical Center.

NCT03702283 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 240 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03702283, a NA study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
NA
Development phase
240 participants
Enrollment target

Study 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)

Primary Outcome

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

Interventions

  • OTHER Penicillin Allergic Risk Stratification Best Practice Alert

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2019-03-31
Est. Completion 2021-03-31
Phase NA

What the finished NCT03702283 record still lists

NCT03702283 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which Penicillin Allergic Risk Stratification Best Practice Alert is the first listed.

NCT03702283 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03702283 about?

NCT03702283 is a clinical study titled "Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting". 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 alle...

What is the current status of trial NCT03702283?

This trial is currently completed. It is a NA study. The enrollment target is 240 participants. The study started on 2019-03-31. Estimated completion is 2021-03-31.

What interventions are being tested in trial NCT03702283?

The interventions under investigation include: Penicillin Allergic Risk Stratification Best Practice Alert (OTHER).

Who is sponsoring clinical trial NCT03702283?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03702283's enrollment target sits among peer trials

240 440th of 2000 higher than 1,542 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03702283, the US trial registry maintained by the National Library of Medicine. NCT03702283 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.