Statistical analysis plan for the BLING III study: A phase 3 multicentre randomised controlled trial of continuous versus intermittent β-lactam antibiotic infusion in critically ill patients with sepsis

Laurent Billot, Jeffrey Lipman, Stephen J. Brett, Jan J. De Waele, Menino Osbert Cotta, Joshua S. Davis, Simon Finfer, Naomi E. Hammond, Serena Knowles, Shay McGuinness, John Myburgh, David L. Paterson, Sandra Peake, Dorrilyn Rajbhandari, Andrew Rhodes, Jason A. Roberts, Claire Roger, Charudatt Shirwadkar, Therese Starr, Colman TaylorJoel M. Dulhunty

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The β-Lactam Infusion Group (BLING) III study is a prospective, multicentre, open, phase 3 randomised controlled trial comparing continuous infusion with intermittent infusion of β-lactam antibiotics in 7000 critically ill patients with sepsis. 

Objective: To describe a statistical analysis plan for the BLING III study. 

Methods: The statistical analysis plan was designed by the trial statistician and chief investigators and approved by the BLING III management committee before the completion of data collection. Statistical analyses for primary, secondary and tertiary outcomes and planned subgroup analyses are described in detail. Interim analysis by the Data Safety and Monitoring Committee (DSMC) has been conducted in accordance with a pre-specified DSMC charter. 

Results and conclusions: The statistical analysis plan for the BLING III study is published before completion of data collection and unblinding to minimise analysis bias and facilitate public access and transparent analysis and reporting of study findings.

Original languageEnglish
Pages (from-to)273-284
Number of pages12
JournalCritical Care and Resuscitation
Volume23
Issue number3
DOIs
Publication statusPublished - Sept 2021

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