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NCT04441021 · ClinicalTrials.gov registry record
Feasibility Assessment of Risk Stratification and Oral Challenge in Hospitalized Children at Low Risk for Antibiotic Allergy
A clinical trial of Penicillin Allergy, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT04441021: Completed study of Penicillin Allergy, sponsored by Vanderbilt University Medical Center.
NCT04441021 is a study of Penicillin Allergy that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 20 participants, below the 215-participant average among 3 other Penicillin Allergy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04441021, a study of Penicillin Allergy, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Children are often reported to have antibiotics allergies, with approximately 10% of the US population labeled as allergic to an antibiotic. Recent studies have demonstrated that a large majority of children with a penicillin allergy label do not have a true IgE-mediated allergy. Appropriately delabeling antibiotic allergies has been shown to improve patient care outcomes and lower health care costs. However, efforts to implement these assessments in practice are lacking, particularly in the hospital setting. Therefore, there is a need for hospital-based risk assessment and delabeling strategies for hospitalized children. The investigator's objective is to determine the feasibility of implementing a hospital-based approach to penicillin allergy risk stratification and evaluation of patients at low-risk for true allergy.
Primary Outcome
Qualitative survey to assess feasibility of intervention
Conditions Studied
Interventions
- OTHER Penicillin Allergy Risk Stratification and Evaluation
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2021-06-29 |
What the finished NCT04441021 record still lists
NCT04441021 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 215-participant average among 3 other Penicillin Allergy trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Penicillin Allergy appearing as the primary indexed condition, and to 1 intervention - of which Penicillin Allergy Risk Stratification and Evaluation is the first listed.
NCT04441021 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04441021 about?
NCT04441021 is a clinical study titled "Feasibility Assessment of Risk Stratification and Oral Challenge in Hospitalized Children at Low Risk for Antibiotic Allergy". Children are often reported to have antibiotics allergies, with approximately 10% of the US population labeled as allergic to an antibiotic. Recent studies have demonstrated that a large majority of children with a penicillin allergy label do not have a true IgE-mediated allergy. Appropriately delab...
What is the current status of trial NCT04441021?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2020-09-15. Estimated completion is 2021-06-29.
What conditions does trial NCT04441021 study?
This clinical trial studies the following conditions: Penicillin Allergy.
What interventions are being tested in trial NCT04441021?
The interventions under investigation include: Penicillin Allergy Risk Stratification and Evaluation (OTHER).
Who is sponsoring clinical trial NCT04441021?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04441021 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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