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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04454229




Registration number
NCT04454229
Ethics application status
Date submitted
25/06/2020
Date registered
1/07/2020
Date last updated
6/03/2023

Titles & IDs
Public title
The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge
Scientific title
The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge - An International Multicenter Randomized Control Trial - The PALACE Study
Secondary ID [1] 0 0
PALACE1
Universal Trial Number (UTN)
Trial acronym
PALACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypersensitivity, Immediate 0 0
Hypersensitivity, Delayed 0 0
Hypersensitivity Response 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Direct oral penicillin challenge
Other interventions - Standard of care

Experimental: Direct oral antibiotic challenge - Direct oral antibiotic (penicillin) challenge in patients with PEN-Fast less than 3.

Active comparator: Standard of care - Standard of care: skin testing and, if negative, oral challenge.


Other interventions: Direct oral penicillin challenge
The patient will receive a single dose of oral penicillin, following baseline vital signs.

Other interventions: Standard of care
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The difference in the proportion of positive oral challenges (i.e. immune-mediated reaction)
Timepoint [1] 0 0
up to 48H after oral challenge
Secondary outcome [1] 0 0
Proportion of patients referred to the outpatient allergy clinic that are eligible for intervention (i.e randomization) as per protocol [Eligibility to screened ratio]
Timepoint [1] 0 0
Before randomization
Secondary outcome [2] 0 0
Feasibility of recruitment defined as the proportion of patients consenting to participate in the study as per protocol from eligible patients. [Recruitment to eligibility ratio].
Timepoint [2] 0 0
Before randomization
Secondary outcome [3] 0 0
Feasibility of intervention delivery defined as the proportion of patients randomized to the intervention arm who had the intervention delivered as per protocol. [Intervention to recruitment ratio]
Timepoint [3] 0 0
Before randomization
Secondary outcome [4] 0 0
The proportion of patients with a penicillin allergy who experience an antibiotic associated immune mediated adverse event OR severe adverse drug reaction as per protocol definitions.
Timepoint [4] 0 0
Up to 48h after the drug challenge
Secondary outcome [5] 0 0
The proportion of patients with a penicillin allergy who experience an antibiotic associated non-immune mediated adverse event.
Timepoint [5] 0 0
Up to 48h after the drug challenge
Secondary outcome [6] 0 0
The proportion of patients that will respect the protocol (protocol compliance)
Timepoint [6] 0 0
Up to 48h after the drug challenge
Secondary outcome [7] 0 0
Proportion of patient with positive Penicillin Skin Testing
Timepoint [7] 0 0
Up to 48h after the drug challenge
Secondary outcome [8] 0 0
Proportion of patients with non-immune mediated positive oral provocation
Timepoint [8] 0 0
Up to 48h after the drug challenge
Secondary outcome [9] 0 0
Proportion of patients with severe adverse reaction - anaphylaxis/death
Timepoint [9] 0 0
Up to 48h after the drug challenge
Secondary outcome [10] 0 0
Time from randomization to delabelling
Timepoint [10] 0 0
Up to 48h after the drug challenge
Secondary outcome [11] 0 0
Number of appointments required for Penicillin delabelling
Timepoint [11] 0 0
Up to 48h after the drug challenge
Secondary outcome [12] 0 0
Assessment with the Pre-Questionnaire and the 6 months follow-up Questionnaire
Timepoint [12] 0 0
Up to 6 months after the drug challenge

Eligibility
Key inclusion criteria
1. Adult patients referred to the outpatient allergy clinic for a penicillin allergy history;
2. Willing and able to give consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient age is < 18 years;
2. Patients with a PEN-FAST score less than 3
3. Pregnancy;
4. Any other illness that, in the investigator's judgement, will substantially increase the risk associated with subject's participation in this study;
5. Patients with history of type A adverse drug reaction, drug-associated anaphylaxis, idiopathic urticaria/anaphylaxis, mastocytosis, serum sickness, blistering skin eruption or acute interstitial nephritis;
6. Patients where the allergy history was not able to be confirmed with patient;
7. Patients on concurrent antihistamine therapy;
8. Patients receiving more than stress dose steroids (i.e. > 50mg QID hydrocortisone [or steroid equivalent]).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/12/2022
Sample size
Target
Accrual to date
Final
382
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Government body
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/29/NCT04454229/SAP_002.pdf



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT04454229