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dc.contributor.authorCampbell AJen
dc.contributor.authorDotel Ren
dc.contributor.authorBraddick Men
dc.contributor.authorBritton PNen
dc.contributor.authorEisen DPen
dc.contributor.authorFrancis JRen
dc.contributor.authorLynar Sen
dc.contributor.authorMcMullan Ben
dc.contributor.authorMeagher Nen
dc.contributor.authorNelson Jen
dc.contributor.authorO'Sullivan MVNen
dc.contributor.authorPrice DJen
dc.contributor.authorRobinson JOen
dc.contributor.authorWhelan Aen
dc.contributor.authorTong SYCen
dc.contributor.authorBowen ACen
dc.contributor.authorDavis JSen
dc.identifier.citation© The Author(s) 2022. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy.en
dc.identifier.citationJAC Antimicrob Resist. 2022 Feb 17;4(1):dlac014. doi: 10.1093/jacamr/dlac014. eCollection 2022 Mar.en
dc.description.abstractBACKGROUND: Combination antibiotic therapy with an antitoxin agent, such as clindamycin, is included in some guidelines for severe, toxin-mediated Staphylococcus aureus infections. The evidence to support this practice is currently limited to in vitro, animal and observational human case-series data, with no previous randomized controlled trials (RCTs). OBJECTIVES: This pilot RCT aimed to determine the feasibility of conducting a clinical trial to examine if adjunctive clindamycin with standard therapy has greater efficacy than standard therapy alone for S. aureus infections. METHODS: We performed an investigator-initiated, open-label, multicentre, pilot RCT (ACTRN12617001416381p) in adults and children with severe S. aureus infections, randomized to standard antibiotic therapy with or without clindamycin for 7 days. RESULTS: Over 28 months, across nine sites, 127 individuals were screened and 34 randomized, including 11 children (32%). The primary outcome-number of days alive and free of systemic inflammatory response syndrome ≤14 days-was similar between groups: clindamycin (3 days [IQR 1-6]) versus standard therapy (4 days [IQR 0-8]). The 90 day mortality was 0% (0/17) in the clindamycin group versus 24% (4/17) in the standard therapy group. Secondary outcomes-microbiological relapse, treatment failure or diarrhoea-were similar between groups. CONCLUSIONS: As the first clinical trial assessing adjunctive clindamycin for S. aureus infections, this study indicates feasibility and that adults and children can be incorporated into one trial using harmonized endpoints, and there were no safety concerns. The CASSETTE trial will inform the definitive S. aureus Network Adaptive Platform (SNAP) trial, which includes an adjunctive clindamycin domain and participants with non-severe disease.en
dc.titleClindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation (CASSETTE)-an open-labelled pilot randomized controlled trial.en
dc.typeJournal Articleen
dc.identifier.journaltitleJAC-antimicrobial resistanceen
dc.description.affiliationDepartment of Infectious Diseases, Perth Children's Hospital, Perth, Australia.en
dc.description.affiliationWesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Australia.en
dc.description.affiliationSchool of Medicine, University of Western Australia, Perth, Australia.en
dc.description.affiliationDepartment of Infectious Diseases, Blacktown Hospital, Sydney, Australia.en
dc.description.affiliationCentre for Infectious Diseases and Microbiology, Westmead Hospital, University of Sydney, Sydney, Australia.en
dc.description.affiliationDepartment of Infectious Diseases, Townsville University Hospital, Townsville, Queensland, Australia.en
dc.description.affiliationDepartment of Infectious Diseases and Microbiology, Children's Hospital Westmead, Sydney, Australia.en
dc.description.affiliationUniversity of Sydney, Discipline of Child and Adolescent Health, Sydney Medical School, Sydney, Australia.en
dc.description.affiliationMarie Bashir Institute for Infectious Diseases and Biosecurity, University of Sydney, Sydney, Australia.en
dc.description.affiliationCollege of Medicine and Dentistry, James Cook University, Townsville, Queensland, Australia.en
dc.description.affiliationGlobal and Tropical Health Division, Menzies School of Health Research, Darwin, Australia.en
dc.description.affiliationDepartment of Paediatrics, Royal Darwin Hospital, Darwin, Australia.en
dc.description.affiliationInfectious Diseases, Royal Darwin Hospital, Northern Territory, Australia.en
dc.description.affiliationDepartment of Immunology and Infectious Diseases, Sydney Children's Hospital, Randwick, Sydney, Australia.en
dc.description.affiliationSchool of Women's and Children's Health, University of New South Wales, Sydney, Australia.en
dc.description.affiliationNational Centre for Infections in Cancer, University of Melbourne, Melbourne, Australia.en
dc.description.affiliationDepartment of Infectious Diseases, Doherty Institute for Infection & Immunity, The University of Melbourne & Royal Melbourne Hospital, Melbourne, Australia.en
dc.description.affiliationCentre for Epidemiology & Biostatistics, Melbourne School of Population & Global Health, University of Melbourne, Melbourne, Australia.en
dc.description.affiliationNew South Wales Health Pathology, Newcastle, Australia.en
dc.description.affiliationDepartment of Infectious Diseases, Royal Perth Hospital, Perth, Australia.en
dc.description.affiliationDepartment of Infectious Diseases, Fiona Stanley Hospital, Perth, Australia.en
dc.description.affiliationDepartment of Microbiology, Pathwest Laboratory Medicine, Perth, Australia.en
dc.description.affiliationCollege of Science, Health, Engineering and Education, Discipline of Health, Murdoch University, Perth, Australia.en
dc.description.affiliationVictorian Infectious Diseases Service, The Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.en
dc.description.affiliationJohn Hunter Hospital, University of Newcastle, Newcastle, Australia.en
dc.description.affiliationSchool of Medicine and Public Health, University of Newcastle, Newcastle, Australia.en
local.issue.number2632-1823 (Electronic)-
local.issue.number2632-1823 (Linking)-
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