Empirical meropenem versus piperacillin/tazobactam for adult patients with sepsis (EMPRESS) trial: Protocol
Study context
- Population
- Adult, critically ill patients with sepsismaximum 14,000 planned
- Planned comparison
- Empirical meropenem vs piperacillin/tazobactam
- Primary endpoint
- All-cause mortality
- Follow-up
- Up to 30 days
Methodological detailsinvestigator-initiated, international, parallel-group, open-label, adaptive, integrated feasibility phase, Bayesian, response-adaptive randomisation, Adaptive analyses after the first 400 participants and after every 300 subsequent participants; stopping for superiority/inferiority and practical equivalence (absolute risk difference <2.5%-points), Expected sample sizes 5189, 5859 and 2570 (no, small or large differences); ≥99% probability of conclusiveness
- Investigator-initiated
- International
- Parallel-group
- Open-label
- Adaptive
- Integrated feasibility phase
- Bayesian
- Response-adaptive randomisation
- Adaptive analyses after the first 400 participants and after every 300 subsequent participants; stopping for superiority/inferiority and practical equivalence (absolute risk difference <2.5%-points)
- Expected sample sizes 5189, 5859 and 2570 (no, small or large differences); ≥99% probability of conclusiveness
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Empirical meropenem versus piperacillin/tazobactam for adult patients with sepsis (EMPRESS) trial: Protocol. Acta Anaesthesiol Scand. Published 20 May 2024. doi:10.
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