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Empirical meropenem...
Empirical meropenem versus piperacillin/tazobactam for adult patients with sepsis (EMPRESS) trial : Protocol
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- Granholm, Anders (author)
- Copenhagen University Hospital
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- Munch, Marie Warrer (author)
- Copenhagen University Hospital
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- Meier, Nick (author)
- CRIC - Collaboration for Research in Intensive Care,Copenhagen University Hospital
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- Sjövall, Fredrik (author)
- Lund University,Lunds universitet,Anestesiologi och intensivvård,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Mitokondriell Medicin,Forskargrupper vid Lunds universitet,Anesthesiology and Intensive Care,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Mitochondrial Medicine,Lund University Research Groups,Skåne University Hospital
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- Helleberg, Marie (author)
- Copenhagen University Hospital,University of Copenhagen
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- Hertz, Frederik Boëtius (author)
- University of Copenhagen,Copenhagen University Hospital
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- Kaas-Hansen, Benjamin Skov (author)
- University of Copenhagen,Copenhagen University Hospital
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- Thorsen-Meyer, Hans Christian (author)
- Copenhagen University Hospital
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- Andersen, Lars Wiuff (author)
- Aarhus University,Aarhus University Hospital
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- Rasmussen, Bodil Steen (author)
- Aalborg University Hospital,Aalborg University
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- Andersen, Jakob Steen (author)
- Copenhagen University Hospital
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Albertsen, Trine Lynge (author)
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- Kjær, Maj Brit Nørregaard (author)
- Copenhagen University Hospital
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- Jensen, Aksel Karl Georg (author)
- University of Copenhagen
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- Lange, Theis (author)
- University of Copenhagen
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- Perner, Anders (author)
- University of Copenhagen,Copenhagen University Hospital
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- Møller, Morten Hylander (author)
- University of Copenhagen,Copenhagen University Hospital
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(creator_code:org_t)
- English.
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In: Acta Anaesthesiologica Scandinavica. - 0001-5172.
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http://dx.doi.org/10... (free)
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Abstract
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- Background: Piperacillin/tazobactam may be associated with less favourable outcomes than carbapenems in patients with severe bacterial infections, but the certainty of evidence is low. Methods: The Empirical Meropenem versus Piperacillin/Tazobactam for Adult Patients with Sepsis (EMPRESS) trial is an investigator-initiated, international, parallel-group, randomised, open-label, adaptive clinical trial with an integrated feasibility phase. We will randomise adult, critically ill patients with sepsis to empirical treatment with meropenem or piperacillin/tazobactam for up to 30 days. The primary outcome is 30-day all-cause mortality. The secondary outcomes are serious adverse reactions within 30 days; isolation precautions due to resistant bacteria within 30 days; days alive without life support and days alive and out of hospital within 30 and 90 days; 90- and 180-day all-cause mortality and 180-day health-related quality of life. EMPRESS will use Bayesian statistical models with weak to somewhat sceptical neutral priors. Adaptive analyses will be conducted after follow-up of the primary outcome for the first 400 participants concludes and after every 300 subsequent participants, with adaptive stopping for superiority/inferiority and practical equivalence (absolute risk difference <2.5%-points) and response-adaptive randomisation. The expected sample sizes in scenarios with no, small or large differences are 5189, 5859 and 2570 participants, with maximum 14,000 participants and ≥99% probability of conclusiveness across all scenarios. Conclusions: EMPRESS will compare the effects of empirical meropenem against piperacillin/tazobactam in adult, critically ill patients with sepsis. Due to the pragmatic, adaptive design with high probability of conclusiveness, the trial results are expected to directly inform clinical practice.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
Keyword
- adaptive clinical trial
- carbapenems
- empirical antibiotics
- meropenem
- piperacillin/tazobactam
- randomised clinical trial
- sepsis
- septic shock
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Granholm, Anders
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Munch, Marie War ...
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Meier, Nick
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Sjövall, Fredrik
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Helleberg, Marie
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Hertz, Frederik ...
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Kaas-Hansen, Ben ...
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Thorsen-Meyer, H ...
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Andersen, Lars W ...
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Rasmussen, Bodil ...
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Andersen, Jakob ...
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Albertsen, Trine ...
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Kjær, Maj Brit N ...
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Jensen, Aksel Ka ...
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Lange, Theis
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Perner, Anders
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Møller, Morten H ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Infectious Medic ...
- Articles in the publication
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Acta Anaesthesio ...
- By the university
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Lund University