Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis
Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis (EMPRESS) Trial
Scandinavian Critical Care Trials Group
5,800 participants
Jun 26, 2025
INTERVENTIONAL
Conditions
Summary
The EMPRESS trial aims to test the two most commonly used antibiotics (meropenem and piperacillin/tazobactam) among intensive care patients with sepsis (blood poisoning), as the safety of these two drugs is unclear in this group of patients.
Eligibility
Inclusion Criteria9
- Age ≥ 18 years
- Sepsis (including septic shock) defined according to the Sepsis-3 criteria (1), i.e., suspected or documented infection and an acute increase of ≥ 2 points in the Sequential Organ Failure Assessment (SOFA) score (a marker of acute organ dysfunction)
- Critical illness defined as use of at least one of the following:
- Invasive mechanical ventilation
- Non-invasive ventilation
- Continuous use of continuous positive airway pressure (CPAP) for hypoxia
- Oxygen supplementation with an oxygen flow of ≥ 10 litres (L)/minute independent of delivery system and total flows
- Continuous infusion of any vasopressor or inotrope (excluding strictly procedure-related infusions)
- Clinical indication for empirical treatment with either meropenem or piperacillin/tazobactam
Exclusion Criteria10
- Preceding intravenous treatment with meropenem or piperacillin/tazobactam for \> 24 hours prior to screening
- Fertile women \< 60 years of age with known pregnancy or positive urine human gonadotropin (hCG) or plasma hCG
- Known hypersensitivity or allergy to beta-lactam antibiotics
- Suspected or documented central nervous system infection
- Known infection/colonialization with microorganism with acquired resistance against meropenem or piperacillin/tazobactam within the previous 3 months (e.g., ESBL-, AmpC- or carbapenemase-producing bacteria)
- Current or planned use of valproate within 30 days from randomisation
- Patient included in another interventional trial where co-enrolment with EMPRESS is not permitted
- Previously randomised into the EMPRESS trial
- Informed consent following inclusion expected to be unobtainable
- Patient under coercive measures
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Interventions
For meropenem, the standard dose is 1 g administered 3 times daily as a 30-minute intravenous (IV) infusion, and the high dose is 2 g administered 3 times daily by extended 3-hour infusion
Standard dose of piperacillin/tazobactam 4/0.5 g administered 4 times daily as a 30-minute intravenous (IV) infusion or 3 times daily by extended 4-hour infusions and the recommended high dose is 4/0.5 g administered 4 times daily by extended 3-hour infusion
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06184659