Status:
RECRUITING
Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis
Lead Sponsor:
Scandinavian Critical Care Trials Group
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 dr...
Detailed Description
Background Piperacillin/tazobactam and meropenem are commonly used as empirical agents for patients with sepsis or septic shock. In a recent systematic review comparing empirical and/or definitive tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2029
Estimated Enrollment :
5800 Patients enrolled
Trial Details
Trial ID
NCT06184659
Start Date
June 26 2025
End Date
March 30 2029
Last Update
July 3 2025
Active Locations (2)
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1
Rigshospitalet
Copenhagen, København Ø, Denmark, 2100
2
Rigshospitalet
Copenhagen, Denmark