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The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe.
Tong, Steven Y C; Mora, Jocelyn; Bowen, Asha C; Cheng, Matthew P; Daneman, Nick; Goodman, Anna L; Heriot, George S; Lee, Todd C; Lewis, Roger J; Lye, David C; Mahar, Robert K; Marsh, Julie; McGlothlin, Anna; McQuilten, Zoe; Morpeth, Susan C; Paterson, David L; Price, David J; Roberts, Jason A; Robinson, J Owen; van Hal, Sebastiaan J; Walls, Genevieve; Webb, Steve A; Whiteway, Lyn; Yahav, Dafna; Davis, Joshua S.
Afiliação
  • Tong SYC; Department of Infectious Diseases University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
  • Mora J; Department of Infectious Diseases University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
  • Bowen AC; Department of Infectious Diseases, Perth Children's Hospital, Perth, Australia.
  • Cheng MP; Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Perth, Australia.
  • Daneman N; Divisions of Infectious Diseases and Medical Microbiology, McGill University Health Centre, Montreal, Canada.
  • Goodman AL; Division of Infectious Diseases, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.
  • Heriot GS; Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
  • Lee TC; Department of Infection, St Thomas Hospital, Guy's and St Thomas NHS Foundation Trust, London, United Kingdom.
  • Lewis RJ; Department of Infectious Diseases University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
  • Lye DC; Clinical Practice Assessment Unit and Division of Infectious Diseases, McGill University, Montreal, Canada.
  • Mahar RK; Berry Consultants, LLC, Austin, Texas, USA.
  • Marsh J; Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California, USA.
  • McGlothlin A; Department of Emergency Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
  • McQuilten Z; National Centre for Infectious Diseases, Singapore.
  • Morpeth SC; Department of Infectious Diseases, Tan Tock Seng Hospital, Singapore.
  • Paterson DL; Yong Loo Lin School of Medicine, Singapore.
  • Price DJ; Lee Kong Chian School of Medicine, Singapore.
  • Roberts JA; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Parkville, Australia.
  • Robinson JO; Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Australia.
  • van Hal SJ; Telethon Kids Institute, Perth Children's Hospital, Perth, Australia.
  • Walls G; Berry Consultants, LLC, Austin, Texas, USA.
  • Webb SA; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.
  • Whiteway L; Department of Haematology, Monash Health, Melbourne, Australia.
  • Yahav D; Department of Infectious Diseases, Middlemore Hospital, Auckland, New Zealand.
  • Davis JS; University of Queensland Centre for Clinical Research, Royal Brisbane and Women's Hospital Campus, Brisbane, Australia.
Clin Infect Dis ; 75(11): 2027-2034, 2022 11 30.
Article em En | MEDLINE | ID: mdl-35717634
ABSTRACT
Staphylococcus aureus bloodstream (SAB) infection is a common and severe infectious disease, with a 90-day mortality of 15%-30%. Despite this, <3000 people have been randomized into clinical trials of treatments for SAB infection. The limited evidence base partly results from clinical trials for SAB infections being difficult to complete at scale using traditional clinical trial methods. Here we provide the rationale and framework for an adaptive platform trial applied to SAB infections. We detail the design features of the Staphylococcus aureus Network Adaptive Platform (SNAP) trial that will enable multiple questions to be answered as efficiently as possible. The SNAP trial commenced enrolling patients across multiple countries in 2022 with an estimated target sample size of 7000 participants. This approach may serve as an exemplar to increase efficiency of clinical trials for other infectious disease syndromes.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções Estafilocócicas / Bacteriemia Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: Clin Infect Dis Assunto da revista: DOENCAS TRANSMISSIVEIS Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Austrália
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Infecções Estafilocócicas / Bacteriemia Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: Clin Infect Dis Assunto da revista: DOENCAS TRANSMISSIVEIS Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Austrália