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NCT04454229 · ClinicalTrials.gov registry record · NA
The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge
A NA study of Hypersensitivity, Immediate and Hypersensitivity, Delayed, sponsored by Austin Health.
- Completed
- Registry status
- NA
- Development phase
- 382
- Enrollment target
- 6
- Study locations
NCT04454229 is a NA study of Hypersensitivity, Immediate and Hypersensitivity, Delayed that has completed, run by Austin Health. The registered enrollment target is 382 participants, above the 124-participant average among 3 other Hypersensitivity, Immediate trials with a reported enrollment target (208% higher). The trial reports 6 study locations across 4 states.
The verdict
NCT04454229, a NA study of Hypersensitivity, Immediate and Hypersensitivity, Delayed, has completed, sponsored by Austin Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 382 participants
- Enrollment target
- 6
- Study locations
Study Summary
Whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. The ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, will improve patient access to testing and utilization of preferred penicillin antibiotics.
Conditions Studied
Interventions
- OTHER Standard of care
- OTHER Direct oral penicillin challenge
Study Locations (6)
Victoria
- Austin Health - Heidelberg
- Peter MacCallum Cancer Center - Melbourne
- Royal Melbourne Hospital - Melbourne
North Carolina
- Duke University Medical Center - Durham
Tennessee
- Vanderbilt University Medical Center - Nashville
Quebec
- McGill University Health Centre (MUHC) - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2022-12-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04454229
The ClinicalTrials.gov registry entry for NCT04454229 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 382 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 124-participant average among 3 other Hypersensitivity, Immediate trials with a reported enrollment target (208% higher). The listed sponsor is Austin Health, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Hypersensitivity, Immediate appearing as the primary indexed condition, and to 2 interventions - of which Standard of care is the first listed.
NCT04454229 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Victoria, North Carolina, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04454229 about?
NCT04454229 is a clinical study titled "The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge". Whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. The ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, wil...
What is the current status of trial NCT04454229?
This trial is currently completed. It is a NA study. The enrollment target is 382 participants. The study started on 2021-07-01. Estimated completion is 2022-12-02.
What conditions does trial NCT04454229 study?
This clinical trial studies the following conditions: Hypersensitivity, Immediate, Hypersensitivity, Delayed, Hypersensitivity Response.
What interventions are being tested in trial NCT04454229?
The interventions under investigation include: Standard of care (OTHER), Direct oral penicillin challenge (OTHER).
Who is sponsoring clinical trial NCT04454229?
This trial is sponsored by Austin Health, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04454229 being conducted?
This trial has 6 study locations across North Carolina, Tennessee, Victoria, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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