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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 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 240 participants.
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)
Interventions
- OTHER Penicillin Allergic Risk Stratification Best Practice Alert
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2019-03-31 |
| Est. Completion | 2021-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03702283
The ClinicalTrials.gov registry entry for NCT03702283 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Penicillin Allergic Risk Stratification Best Practice Alert is the first listed.
NCT03702283 reports 0 study locations.
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.
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