Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Hypersensitivity, Immediate and Hypersensitivity, Delayed, sponsored by Austin Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT04454229 record still lists
NCT04454229 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, above the 124-participant average among 3 other Hypersensitivity, Immediate trials with a reported enrollment target (208% higher).
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 lists 6 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Hypersensitivity, Immediate
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05677490 · 382 participants · Phase 3
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
- NCT06196008 · 382 participants · NA
Telephone-based Physical Activity Coaching or Self Monitored Physical Activity to Improve Physical Function in Older Adults Who Are Undergoing Surgery for Lung Cancer and Their Caregivers
- NCT07100990 · 382 participants · Phase 3
Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
- NCT06056830 · 383 participants · Phase 3
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI