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The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge
NCT04454229 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 382 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Austin Health, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04454229 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Victoria, North Carolina, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04454229?
The interventions under investigation include: Standard of care (OTHER), Direct oral penicillin challenge (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04454229?
This trial is sponsored by Austin Health, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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