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Sökning: WFRF:(Granholm Anders) > Empirical meropenem...

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00005114naa a2200553 4500
001oai:lup.lub.lu.se:6c1f380b-16e8-45c8-b548-141c8b1f1c73
003SwePub
008240614| | |||||||||||000 ||eng|
0247 a https://lup.lub.lu.se/record/6c1f380b-16e8-45c8-b548-141c8b1f1c732 URI
0247 a https://doi.org/10.1111/aas.144412 DOI
040 a (SwePub)lu
041 a engb eng
042 9 SwePub
072 7a art2 swepub-publicationtype
072 7a ref2 swepub-contenttype
1001 a Granholm, Andersu Copenhagen University Hospital4 aut
2451 0a Empirical meropenem versus piperacillin/tazobactam for adult patients with sepsis (EMPRESS) trial : Protocol
520 a 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Infektionsmedicin0 (SwePub)302092 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Infectious Medicine0 (SwePub)302092 hsv//eng
653 a adaptive clinical trial
653 a carbapenems
653 a empirical antibiotics
653 a meropenem
653 a piperacillin/tazobactam
653 a randomised clinical trial
653 a sepsis
653 a septic shock
7001 a Munch, Marie Warreru Copenhagen University Hospital4 aut
7001 a Meier, Nicku Copenhagen University Hospital,CRIC - Collaboration for Research in Intensive Care4 aut
7001 a Sjövall, Fredriku 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 Hospital4 aut0 (Swepub:lu)expb-fsa
7001 a Helleberg, Marieu Copenhagen University Hospital,University of Copenhagen4 aut
7001 a Hertz, Frederik Boëtiusu University of Copenhagen,Copenhagen University Hospital4 aut
7001 a Kaas-Hansen, Benjamin Skovu Copenhagen University Hospital,University of Copenhagen4 aut
7001 a Thorsen-Meyer, Hans Christianu Copenhagen University Hospital4 aut
7001 a Andersen, Lars Wiuffu Aarhus University,Aarhus University Hospital4 aut
7001 a Rasmussen, Bodil Steenu Aalborg University Hospital,Aalborg University4 aut
7001 a Andersen, Jakob Steenu Copenhagen University Hospital4 aut
7001 a Albertsen, Trine Lynge4 aut
7001 a Kjær, Maj Brit Nørregaardu Copenhagen University Hospital4 aut
7001 a Jensen, Aksel Karl Georgu University of Copenhagen4 aut
7001 a Lange, Theisu University of Copenhagen4 aut
7001 a Perner, Andersu Copenhagen University Hospital,University of Copenhagen4 aut
7001 a Møller, Morten Hylanderu University of Copenhagen,Copenhagen University Hospital4 aut
7102 a Copenhagen University Hospitalb CRIC - Collaboration for Research in Intensive Care4 org
7730 t Acta Anaesthesiologica Scandinavicax 0001-5172
8564 u http://dx.doi.org/10.1111/aas.14441x freey FULLTEXT
8564 8u https://lup.lub.lu.se/record/6c1f380b-16e8-45c8-b548-141c8b1f1c73
8564 8u https://doi.org/10.1111/aas.14441

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