Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/33386
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dc.contributor.authorRose, Morgan T-
dc.contributor.authorHolmes, Natasha E-
dc.contributor.authorEastwood, Glenn M-
dc.contributor.authorVogrin, Sara-
dc.contributor.authorJames, Fiona L-
dc.contributor.authorPhung, Michelle-
dc.contributor.authorBarnes, Sara-
dc.contributor.authorMurfin, Brendan-
dc.contributor.authorRogers, Ben-
dc.contributor.authorLambros, Belinda-
dc.contributor.authorPeel, Trisha-
dc.contributor.authorGibney, Grace-
dc.contributor.authorSlavin, Monica-
dc.contributor.authorTrubiano, Jason-
dc.date2023-
dc.date.accessioned2023-07-26T06:36:59Z-
dc.date.available2023-07-26T06:36:59Z-
dc.date.issued2023-07-20-
dc.identifier.citationPilot and Feasibility Studies 2023-07-20; 9(1)en_US
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/33386-
dc.description.abstractSelf-reported penicillin allergies are highly prevalent in hospitalised patients and are associated with poor health and health service outcomes. Critically ill patients have historically been underrepresented in prospective delabelling studies in part due to concerns around clinical stability and reliability of penicillin skin testing. Allergy assessment tools exist to identify low-risk penicillin allergy phenotypes and facilitate direct oral challenge delabelling. PEN-FAST is a clinical decision rule that has been validated to predict true penicillin allergy in a cohort of non-critically ill patients. There is however limited evidence regarding the feasibility, safety and efficacy of direct oral challenges and the use of delabelling clinical decisions rules in the intensive care setting. Critically ill patients in the intensive care unit (ICU) with low-risk penicillin allergy phenotypes (PEN-FAST score < 3) will be randomised 1:1 to direct oral penicillin challenge (single dose 250 mg oral amoxicillin or implicated penicillin) or routine care, followed by a 2-h observation period. Patients will receive a second oral challenge/observation prior to hospital discharge (with subsequent observation for 2 h). An assessment for antibiotic-associated adverse events will also be undertaken at 24 h and 5 days post each challenge/observation and again at 90 days post-randomisation. The primary outcome measures are feasibility (proportion of eligible patients recruited and protocol compliance) and safety (proportion of patients who experience an antibiotic-associated immune-mediated adverse event or serious adverse event). We will report the feasibility and safety of point-of-care penicillin direct oral challenge in this first randomised controlled trial of low-risk penicillin allergy in critically ill hospitalised patients. Upon completion of the project, important findings will inform the design of planned large prospective multi-centre clinical trials in Australian and international ICUs, further examining safety and efficacy and exploring antimicrobial prescribing-related outcomes following penicillin oral challenge. Australian New Zealand Clinical Trials Registry Registration Number: ACTRN12621000051842 Date registered: 20/01/2021 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379735&isReview=true.en_US
dc.language.isoeng-
dc.subjectAllergyen_US
dc.subjectAntibioticsen_US
dc.subjectCritical illnessen_US
dc.subjectDelabellingen_US
dc.subjectIntensive careen_US
dc.subjectPenicillinen_US
dc.titleOral challenge vs routine care to assess low-risk penicillin allergy in critically ill hospital patients (ORACLE): a pilot randomised controlled trial.en_US
dc.typeJournal Articleen_US
dc.identifier.journaltitlePilot and Feasibility Studiesen_US
dc.identifier.affiliationCentre for Antibiotic Allergy and Researchen_US
dc.identifier.affiliationDepartment of Infectious Diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.;Data Analytics Research and Evaluation Centre, Austin Health/University of Melbourne, Heidelberg, VIC, Australia.;Department of Critical Care, The University of Melbourne, Parkville, VIC, Australia.en_US
dc.identifier.affiliationIntensive Careen_US
dc.identifier.affiliationDepartment of Medicine (St Vincent's Hospital), University of Melbourne, Melbourne, VIC, Australia.en_US
dc.identifier.affiliationCentre for Antibiotic Allergy and Research, Department of Infectious Diseases, Austin Health, Level 7, Harold Stokes Building, 145 Studley Road, Heidelberg, VIC, 3084, Australia.en_US
dc.identifier.affiliationPharmacy Department, Monash Health, Clayton, VIC, Australia.;Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, VIC, Australia.en_US
dc.identifier.affiliationMonash Lung Sleep Allergy and Immunology, Monash Health, Clayton, VIC, Australia.en_US
dc.identifier.affiliationIntensive Care Unit, Monash Health, Clayton, VIC, Australia.en_US
dc.identifier.affiliationMonash Infectious Diseases, Monash Health, Clayton, VIC, Australia.;School of Clinical Sciences, Monash University, Clayton, VIC, Australia.en_US
dc.identifier.affiliationNational Centre for Infections in Cancer, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.;Department of Infectious Diseases, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.en_US
dc.identifier.affiliationDepartment of Infectious Diseases, Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.;Department of Infectious Diseases, Alfred Health, Melbourne, VIC, Australia.en_US
dc.identifier.affiliationCentre for Antibiotic Allergy and Research, Department of Infectious Diseases, Austin Health, Level 7, Harold Stokes Building, 145 Studley Road, Heidelberg, VIC, 3084, Australia.en_US
dc.identifier.affiliationNational Centre for Infections in Cancer, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.;Department of Infectious Diseases, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.;Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, VIC, Australia.;Immunocompromised Host Infection Service, Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, VIC, Australia.en_US
dc.identifier.doi10.1186/s40814-023-01337-8en_US
dc.type.contentTexten_US
dc.identifier.orcid0000-0001-8714-5998en_US
dc.identifier.pubmedid37475038-
dc.description.volume9-
dc.description.issue1-
dc.description.startpage126-
local.name.researcherEastwood, Glenn M
item.languageiso639-1en-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.openairetypeJournal Article-
crisitem.author.deptInfectious Diseases-
crisitem.author.deptInfectious Diseases-
crisitem.author.deptData Analytics Research and Evaluation (DARE) Centre-
crisitem.author.deptIntensive Care-
crisitem.author.deptInfectious Diseases-
crisitem.author.deptCentre for Antibiotic Allergy and Research-
crisitem.author.deptInfectious Diseases-
crisitem.author.deptMedicine (University of Melbourne)-
crisitem.author.deptCentre for Antibiotic Allergy and Research-
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