CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 382 enrolled
Drug / intervention
Direct oral penicillin challenge +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04454229
NCT04454229N/ACompleted

The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge - An International Multicenter Randomized Control Trial - The PALACE Study

Austin Health·interventional·Posted Jul 1, 2020·Updated Mar 6, 2023

In Brief

A clinical study evaluating Direct oral penicillin challenge and Standard of care for Hypersensitivity, Immediate and 2 related conditions. Completed, enrolled 382 participants across 6 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, United States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 1, 2020
Enrollment StartJul 1, 2021
Primary CompletionDec 2, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.0 years ago

Interventions

Direct oral penicillin challengeother

The patient will receive a single dose of oral penicillin, following baseline vital signs.

Standard of careother

Routine management as per the treating clinicians that include skin prick and intradermal beta-lactam testing, followed by oral penicillin challenge in the setting of negative skin testing.