Early Oral Antibiotic Switch in Staphylococcus aureus Bacteraemia: The Staphylococcus aureus Network Adaptive Platform (SNAP) Trial Early Oral Switch Protocol

Dana de Kretser; Jocelyn Mora; Max Bloomfield; Anita Campbell; Matthew P Cheng; Stephen Guy; Marjolein Hensgens; Shirin Kalimuddin; Todd C Lee; Amy Legg; Robert K Mahar; Michael Marks; Julie Marsh; Anna McGlothin; Susan C Morpeth; Archana Sud; Jaap Ten Oever; Dafna Yahav; Marc Bonten; Asha C Bowen; Nick Daneman; Sebastiaan J van Hal; George S Heriot; Roger J Lewis; David C Lye; Zoe McQuilten; David L Paterson; J Owen Robinson; Jason A Roberts; Matthew Scarborough; Steve A Webb; Lynda Whiteway; Steven Y C Tong; Joshua S Davis; Genevieve Walls; Anna L Goodman; SNAP Early Oral Switch Domain-Specific Working Group and SNAP Global Trial Steering Committee

doi:10.1093/cid/ciad666

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Early Oral Antibiotic Switch in Staphylococcus aureus Bacteraemia: The Staphylococcus aureus Network Adaptive Platform (SNAP) Trial Early Oral Switch Protocol

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Early Oral Antibiotic Switch in Staphylococcus aureus Bacteraemia: The Staphylococcus aureus Network Adaptive Platform (SNAP) Trial Early Oral Switch Protocol

Dana de Kretser, Jocelyn Mora, Max Bloomfield, Anita Campbell, Matthew P Cheng, Stephen Guy, Marjolein Hensgens, Shirin Kalimuddin, Todd C Lee, Amy Legg, …

Clinical infectious diseases, Vol.79(4), pp.871-887

15/10/2024

DOI: https://doi.org/10.1093/cid/ciad666

PMID: 37921609

Résumé

Adaptive Clinical Trials as Topic

Administration, Intravenous

Administration, Oral

Adult

Anti-Bacterial Agents - administration & dosage

Anti-Bacterial Agents - therapeutic use

Bacteremia - drug therapy

Bacteremia - microbiology

Female

Humans

Male

Randomized Controlled Trials as Topic

Staphylococcal Infections - drug therapy

Staphylococcal Infections - microbiology

Staphylococcus aureus - drug effects

Staphylococcus aureus bloodstream infection (bacteremia) is traditionally treated with at least 2 weeks of intravenous (IV) antibiotics in adults, 3-7 days in children, and often longer for those with complicated disease. The current practice of treating S. aureus bacteremia (SAB) with prolonged IV antibiotics (rather than oral antibiotics) is based on historical observational research and expert opinion. Prolonged IV antibiotic therapy has significant disadvantages for patients and healthcare systems, and there is growing interest in whether a switch to oral antibiotics following an initial period of IV therapy is a safe alternative for clinically stable patients. The early oral switch (EOS) domain of the S. aureus Network Adaptive Platform (SNAP) trial will assess early switch to oral antibiotics compared with continued IV treatment in clinically stable patients with SAB. The primary endpoint is 90-day all-cause mortality. Hospitalised SAB patients are assessed at platform day 7 ±2 (uncomplicated SAB) and day 14 ±2 (complicated SAB) to determine their eligibility for randomization to EOS (intervention) or continued IV treatment (current standard of care). Recruitment is occurring in the EOS domain of the SNAP trial. As of August 2023, 21% of all SNAP participants had been randomized to the EOS domain, a total of 264 participants across 77 centers, with an aim to recruit at least 1000 participants. We describe challenges and facilitators to enrolment in this domain to aid those planning similar trials.

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Titre: Early Oral Antibiotic Switch in Staphylococcus aureus Bacteraemia: The Staphylococcus aureus Network Adaptive Platform (SNAP) Trial Early Oral Switch Protocol
Créateurs - sans rôle: Dana de Kretser - Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom
Jocelyn Mora - Department of Infectious Diseases University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia
Max Bloomfield - Department of Infection Services, Wellington Regional Hospital, New Zealand
Anita Campbell - Telethon Kids Institute, Wesfarmers Center of Infectious Diseases and Vaccines, The University of Western Australia, Perth, Australia
Matthew P Cheng - Divisions of Infectious Diseases and Medical Microbiology, McGill University Health Center, Montreal, Canada
Stephen Guy - Monash University (including Australian and New Zealand Intensive Care Research Centre), Clayton, Australia
Marjolein Hensgens - Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands
Shirin Kalimuddin - Program in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore, Singapore
Todd C Lee - Clinical Practice Assessment Unit and Division of Infectious Diseases, McGill University, Montreal, Canada
Amy Legg - Herston Infectious Diseases Institute, Herston, Brisbane, Australia
Robert K Mahar - Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Australia
Michael Marks - Division of Infection and Immunity, University College London, London
Julie Marsh - Telethon Kids Institute &/Department of Infectious Diseases &/Wesfarmers Centre for Vaccines and Infectious Diseases, Perth Children's Hospital, Perth, Australia
Anna McGlothin - Berry Consultants, LLC, Austin, Texas, USA
Susan C Morpeth - Department of Infectious Diseases, Middlemore Hospital, Auckland, New Zealand
Archana Sud - Department of Infectious Diseases, University of Sydney, Nepean Hospital, Kingswood, New South Wales, Australia
Jaap Ten Oever - Department of Internal Medicine and Radboud Centre for Infectious Diseases, Radboud University Medical Center Nijmegen, The Netherlands
Dafna Yahav - Infectious Diseases Unit, Sheba Medical Center, Ramat-Gan, Israel
Marc Bonten - UMC Utrecht, Utrecht University, Utrecht, The Netherlands
Asha C Bowen - Telethon Kids Institute &/Department of Infectious Diseases &/Wesfarmers Centre for Vaccines and Infectious Diseases, Perth Children's Hospital, Perth, Australia
Nick Daneman - Division of Infectious Diseases, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada
Sebastiaan J van Hal - School of Medicine, University of Sydney, Sydney, Australia
George S Heriot - Department of Infectious Diseases University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia
Roger J Lewis - Berry Consultants, LLC, Austin, Texas, USA
David C Lye - Lee Kong Chian School of Medicine, Singapore
Zoe McQuilten - Department of Haematology, Monash Health, Melbourne, Australia
David L Paterson - University of Queensland Centre for Clinical Research, Royal Brisbane and Women's Hospital Campus, Brisbane, Australia
J Owen Robinson - College of Science, Health, Engineering and Education, Murdoch University, Murdoch, Australia
Jason A Roberts - Division of Anesthesiology Critical Care Emergency and Pain Medicine, Nîmes University Hospital, University of Montpellier, Nîmes, France
Matthew Scarborough - Department of Infectious Diseases, Oxford University Hospitals NHS Trust, Oxford, United Kingdom
Steve A Webb - Department of Infectious Diseases, Oxford University Hospitals NHS Trust, Oxford, United Kingdom
Lynda Whiteway
Steven Y C Tong - Victorian Infectious Diseases Service, The Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia
Joshua S Davis - School of Medicine and Public Health and Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia
Genevieve Walls - Department of Infectious Diseases, Middlemore Hospital, Auckland, New Zealand
Anna L Goodman - Centre for Clinical Infection and Diagnostics Research, Guy's and St Thomas' Foundation NHS Trust, King's College, London, United Kingdom
SNAP Early Oral Switch Domain-Specific Working Group and SNAP Global Trial Steering Committee
Détails de publication: Clinical infectious diseases, Vol.79(4), pp.871-887
Note de subvention: Singapore National Medical Research Council United Kingdom National Institute for Health and Care Research Advancing Queensland Clinical Fellowship Counties Manukau Tupu Health Fund Starship Foundation Australian National Health and Medical Research Council National Health and Medical Research Council CIHR MC_UU_00004/05 / Medical Research Council Te Niwha Infectious Diseases Research Fund
Identifiants: 99155041109311
Unité académique: Initial MAnagement & prevent of acute orGan failures IN critically ill patiEnts - IMAGINE
Langue: English
Type de ressource: Journal article