Early oral antibiotic switch in Staphylococcus aureus bacteraemia: The Staphylococcus aureus Network Adaptive Platform (SNAP) Trial Early Oral Switch Protocol.

S. aureus Staphylococcus aureus adaptive platform bacteraemia bacteremia bloodstream infection clinical trial intravenous antibiotic oral antibiotic parenteral therapy

Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213

Informations de publication

Date de publication:
31 Oct 2023
Historique:
received: 06 06 2023
revised: 07 09 2023
accepted: 20 10 2023
medline: 3 11 2023
pubmed: 3 11 2023
entrez: 3 11 2023
Statut: aheadofprint

Résumé

Staphylococcus aureus bloodstream infection (bacteraemia) is traditionally treated with at least two weeks of IV antibiotics in adults, 3-7 days in children, and often longer for those with complicated disease. The current practice of treating S. aureus bacteraemia (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 randomisation to EOS (intervention) or continued IV treatment (current standard of care). Recruitment is occurring to the EOS domain of the SNAP trial. As of August 2023, 21% of all SNAP participants had been randomised to the EOS domain, a total of 264 participants across 77 centres, 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.

Sections du résumé

BACKGROUND BACKGROUND
Staphylococcus aureus bloodstream infection (bacteraemia) is traditionally treated with at least two weeks of IV antibiotics in adults, 3-7 days in children, and often longer for those with complicated disease. The current practice of treating S. aureus bacteraemia (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.
PROTOCOL METHODS
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 randomisation to EOS (intervention) or continued IV treatment (current standard of care).
DISCUSSION CONCLUSIONS
Recruitment is occurring to the EOS domain of the SNAP trial. As of August 2023, 21% of all SNAP participants had been randomised to the EOS domain, a total of 264 participants across 77 centres, 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.

Identifiants

DOI: 10.1093/cid/ciad666 PMID: 37921609
pubmed: 37921609
pii: 7334281
doi: 10.1093/cid/ciad666
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Investigateurs

Asha C Bowen (AC)
Nick Daneman (N)
Sebastiaan J van Hal (SJ)
George S Heriot (GS)
Roger J Lewis (RJ)
David C Lye (DC)
Zoe McQuilten (Z)
David L Paterson (DL)
J Owen Robinson (JO)
Jason A Roberts (JA)
Matthew Scarborough (M)
Steve A Webb (SA)
Lynda Whiteway (L)

Informations de copyright

© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Auteurs

Dana de Kretser (D)

Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.

Jocelyn Mora (J)

Department of Infectious Diseases University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.

Max Bloomfield (M)

Department of Infection Services, Wellington Regional Hospital, New Zealand.

Anita Campbell (A)

Telethon Kids Institute, Wesfarmers Centre of Infectious Diseases and Vaccines, The University of Western Australia, Perth, Australia.

Matthew P Cheng (MP)

Divisions of Infectious Diseases and Medical Microbiology, McGill University Health Centre, Montreal, Canada.

Stephen Guy (S)

Department of Infectious Diseases, Eastern Health, Box Hill, 3128, Australia.
Monash University (including Australian and New Zealand Intensive Care Research Centre), Clayton, 3800, Australia, Australia.

Marjolein Hensgens (M)

UMC Utrecht, Utrecht University, Utrecht, the Netherlands.
Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.

Shirin Kalimuddin (S)

Department of Infectious Diseases, Singapore General Hospital, 169608, Singapore, Singapore.
Program in Emerging Infectious Diseases, Duke-NUS Medical School, 169857, Singapore, Singapore.

Todd C Lee (TC)

Clinical Practice Assessment Unit and Division of Infectious Diseases, McGill University, Montreal, Canada.

Amy Legg (A)

Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Herston Infectious Diseases Institute, Herston, Brisbane, Australia.

Robert K Mahar (RK)

Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Parkville, Australia.
Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Australia.

Michael Marks (M)

Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, United Kingdom.
Hospital for Tropical Diseases, University College London Hospital, London.
Division of Infection and Immunity, University College London, London.

Julie Marsh (J)

Telethon Kids Institute &/Department of Infectious Diseases &/Wesfarmers Centre for Vaccines and Infectious Diseases, Perth Children's Hospital, Perth, Australia.

Anna McGlothlin (A)

Berry Consultants, LLC, Austin, Texas, USA.

Susan C Morpeth (SC)

Middlemore Hospital, Auckland, New Zealand.

Archana Sud (A)

Department of Infectious Diseases, University of Sydney, Nepean Hospital, Kingswood, New South Wales, Australia.

Jaap Ten Oever (J)

Department of Internal Medicine and Radboud Centre for Infectious Diseases, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands.

Dafna Yahav (D)

Infectious Diseases Unit, Sheba Medical Center, Ramat-Gan, Israel.

Steven Yc Tong (SY)

Department of Infectious Diseases University of Melbourne, Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.
Victorian Infectious Diseases Service, The Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia.

Joshua S Davis (JS)

School of Medicine and Public Health and Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia.

Genevieve Walls (G)

Middlemore Hospital, Auckland, New Zealand.

Anna L Goodman (AL)

Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
Department of Infectious Diseases, Guy's and St Thomas' Foundation NHS Trust, London, UK.

Marc Bonten (M)

UMC Utrecht, Utrecht University, Utrecht, the Netherlands.

Classifications MeSH