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NCT03702270 · ClinicalTrials.gov registry record · NA
The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 2,052
- Enrollment target
NCT03702270 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 2,052 participants.
The verdict
NCT03702270, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,052 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. 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.
Interventions
- OTHER Penicillin Allergic Risk Stratification Best Practice Alert
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,052 participants |
| Start Date | 2020-11-11 |
| Est. Completion | 2023-05-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03702270
The ClinicalTrials.gov registry entry for NCT03702270 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2,052 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.
NCT03702270 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03702270 about?
NCT03702270 is a clinical study titled "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 alle...
What is the current status of trial NCT03702270?
This trial is currently completed. It is a NA study. The enrollment target is 2,052 participants. The study started on 2020-11-11. Estimated completion is 2023-05-11.
What interventions are being tested in trial NCT03702270?
The interventions under investigation include: Penicillin Allergic Risk Stratification Best Practice Alert (OTHER).
Who is sponsoring clinical trial NCT03702270?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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