Who is sponsoring NCT04454229?

NCT04454229 is sponsored by Austin Health.

What drugs are being tested in NCT04454229?

Interventions in NCT04454229: Direct oral penicillin challenge, Standard of care.

What condition does NCT04454229 study?

NCT04454229 studies Hypersensitivity, Immediate, Hypersensitivity, Delayed, Hypersensitivity Response.

Is NCT04454229 still recruiting?

NCT04454229 is currently completed. Last updated 6 March 2023.

Last reviewed 2023-03-06 · How we verify

NCT04454229: PALACE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge

Completed NA Last updated 6 March 2023

What this trial tests

NA trial testing Direct oral penicillin challenge in Hypersensitivity, Immediate in 382 participants. Completed in 2 December 2022.

Timeline

1 July 2021

Primary endpoint
2 December 2022

2 December 2022

Quick facts

Lead sponsor	Austin Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	382
Start date	1 July 2021
Primary completion	2 December 2022
Estimated completion	2 December 2022
Sites	6 locations across Canada, United States, Australia

Drugs / interventions tested

Direct oral penicillin challenge
Standard of care

Conditions studied

Hypersensitivity, Immediate — all drugs for Hypersensitivity, Immediate →
Hypersensitivity, Delayed — all drugs for Hypersensitivity, Delayed →
Hypersensitivity Response — all drugs for Hypersensitivity Response →

Sponsor

Austin Health — full company profile →

Who can join

18 and older, any sex, with Hypersensitivity, Immediate or Hypersensitivity, Delayed. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy of a Clinical Decision Rule to Enable Direct Oral Challenge in Patients With Low-Risk Penicillin Allergy: The PALACE Randomized Clinical Trial.
Copaescu AM, Vogrin S, James F, Chua KYL, et al · · 2023 · cited 128× · PMID 37459086 · DOI 10.1001/jamainternmed.2023.2986
Use of a penicillin allergy clinical decision rule to enable direct oral penicillin provocation: an international multicentre randomised control trial in an adult population (PALACE): study protocol.
Copaescu AM, James F, Vogrin S, Rose M, et al · · 2022 · cited 15× · PMID 35940831 · DOI 10.1136/bmjopen-2022-063784
Risk of Self-Reported Penicillin Allergy Despite Removal of Penicillin Allergy Label: Secondary Analysis of the PALACE Randomized Clinical Trial.
Copaescu AM, Vogrin S, Douglas A, Turner NA, et al · · 2024 · cited 5× · PMID 39145980 · DOI 10.1001/jamanetworkopen.2024.29621

Verify or expand the search:

Other recruiting trials for Hypersensitivity, Immediate

Currently open trials in the same condition.

NCT05420935 — Repertoire and Properties of Anti-drug Antibodies Involved in Immediate Hypersensitivity in the Operating Room · NA · recruiting

Other Austin Health trials

Trials by the same sponsor.

NCT07535580 — Patient-Reported Stent Symptom Outcomes and Migration Rates Following Modified Single-J Ureteric Stent Insertion After U · NA · completed
NCT06916819 — Food Challenge at Home or in Medical Practice - the FoodCHOMP Study · NA · recruiting
NCT04344964 — Endoscopy-related Phone Consultation During the COVID-19 Outbreak · completed
NCT03610061 — A Trial of Radiotherapy and Durvalumab in DLBCL and FL · Phase 1 · completed
NCT02770040 — Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04454229 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Austin Health
Last refreshed: 6 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04454229.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing