Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/30721
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dc.contributor.authorCopaescu, Ana-
dc.contributor.authorJames, Fiona L-
dc.contributor.authorVogrin, Sara-
dc.contributor.authorRose, Morgan T-
dc.contributor.authorChua, Kyra Y L-
dc.contributor.authorHolmes, Natasha E-
dc.contributor.authorTurner, Nicholas A-
dc.contributor.authorStone, Cosby-
dc.contributor.authorPhillips, Elizabeth-
dc.contributor.authorTrubiano, Jason-
dc.date2022-
dc.date.accessioned2022-08-16T06:58:00Z-
dc.date.available2022-08-16T06:58:00Z-
dc.date.issued2022-08-08-
dc.identifier.citationBMJ Open 2022; 12(8): e063784en
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/30721-
dc.description.abstractPenicillin allergies are highly prevalent in the healthcare setting and associated with the prescription of second-line inferior antibiotics. More than 85% of all penicillin allergy labels can be removed by skin testing and 96%-99% of low-risk penicillin allergy labels can be removed by direct oral challenge. An internally and externally validated clinical assessment tool for penicillin allergy, PEN-FAST, can identify a low-risk penicillin allergy without the need for skin testing; a score of less than 3 has a negative predictive value of 96.3% (95% CI, 94.1 to 97.8) for the presence of a penicillin allergy. It is hypothesised that PEN-FAST is a safe and effective tool for assessing penicillin allergy in an outpatient clinic setting. This is an international, multicentre randomised control trial using the PEN-FAST tool to risk-stratify penicillin allergy labels in adult outpatients. The study's primary objective is to evaluate the non-inferiority of using PEN-FAST score-guided management with direct oral challenge compared with standard care (defined as prick and intradermal skin testing followed by oral penicillin challenge). Participants will be randomised 1:1 to the intervention arm (direct oral penicillin challenge) or standard of care arm (skin testing followed by oral penicillin challenge, if skin testing is negative). The sample size of 380 randomised patients (190 per treatment arm) is required to demonstrate non-inferiority. The study will be performed according to the guidelines of the Helsinki Declaration and is approved by the Austin Health Human Research Ethics Committee (HREC/62425/Austin-2020) in Melbourne Australia, Vanderbilt University Institutional Review Board (IRB #202174) in Tennessee, USA, Duke University Institutional Review Board (IRB #Pro00108461) in North Carolina, USA and McGill University Health Centre Research Ethics Board in Canada (PALACE/2022-7605). The results of this study will be published and presented in various scientific forums. NCT04454229.en
dc.language.isoeng-
dc.subjectIMMUNOLOGYen
dc.subjectINFECTIOUS DISEASESen
dc.subjectProtocols & guidelinesen
dc.subjectPublic healthen
dc.titleUse 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.en
dc.typeJournal Articleen
dc.identifier.journaltitleBMJ Openen
dc.identifier.affiliationThe National Centre for Infections in Cancer, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia..en
dc.identifier.affiliationCentre for Antibiotic Allergy and Researchen
dc.identifier.affiliationDepartment of Medicine, St Vincent's Hospital, University of Melbourne, Fitzroy, Victoria, Australia..en
dc.identifier.affiliationInstitute for Immunology and Infectious Diseases, Murdoch University, Murdoch, Western Australia, Australia..en
dc.identifier.affiliationDepartment of Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia..en
dc.identifier.affiliationMedicine (University of Melbourne)en
dc.identifier.affiliationDepartment of Critical Care, Melbourne Medical School, The University of Melbourne, Parkville, Victoria, Australia..en
dc.identifier.affiliationDepartment of Infectious Diseases, Vanderbilt University Medical Center, Nashville, Tennessee, USA..en
dc.identifier.affiliationDepartment of Infectious Diseases, Duke University Medical Center, Durham, Carolina, USA..en
dc.identifier.affiliationDepartment of Medicine, Division of Allergy and Clinical Immunology, McGill University Health Centre (MUHC), Montreal, Quebec, Canada..en
dc.identifier.affiliationThe Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada..en
dc.identifier.affiliationInfectious Diseasesen
dc.identifier.pubmedurihttps://pubmed.ncbi.nlm.nih.gov/35940831/en
dc.identifier.doi10.1136/bmjopen-2022-063784en
dc.type.contentTexten
dc.identifier.orcid0000-0002-9183-5032en
dc.identifier.orcid0000-0003-0469-5666en
dc.identifier.orcid0000-0002-5111-6367en
dc.identifier.orcid0000-0001-8714-5998en
dc.identifier.orcid0000-0001-8826-7137en
dc.identifier.orcid0000-0002-5111-6367en
dc.identifier.pubmedid35940831-
local.name.researcherChua, Kyra Y L-
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.grantfulltextnone-
item.languageiso639-1en-
item.cerifentitytypePublications-
crisitem.author.deptInfectious Diseases-
crisitem.author.deptInfectious Diseases-
crisitem.author.deptCentre for Antibiotic Allergy and Research-
crisitem.author.deptInfectious Diseases-
crisitem.author.deptMicrobiology-
crisitem.author.deptInfectious Diseases-
crisitem.author.deptInfectious Diseases-
crisitem.author.deptData Analytics Research and Evaluation (DARE) Centre-
crisitem.author.deptInfectious Diseases-
crisitem.author.deptMedicine (University of Melbourne)-
crisitem.author.deptCentre for Antibiotic Allergy and Research-
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