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Empirical Meropenem versus Piperacillin/Tazobactam for Adult Patients with Sepsis (EMPRESS)
EU CTIS ID: 2023-509703-33-00
What this study is testing
To assess the effects of empirical meropenem versus piperacillin/tazobactam on mortality and other patient-important outcomes in critically ill adults with sepsis.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Sepsis (including septic shock) defined according to the Sepsis-3 criteria, 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: a. Invasive mechanical ventilation b. Non-invasive ventilation c. Continuous use of continuous positive airway pressure (CPAP) for hypoxia d. Oxygen supplementation with an oxygen flow of ≥ 10 litres (L)/minute independent of delivery system and total flows e. Continuous infusion of any vasopressor or inotrope (excluding strictly procedure-related infusions)
- Clinical indication for empirical treatment with either meropenem or piperacillin/tazobactam
You likely can't join if
- Preceding intravenous treatment with meropenem or piperacillin/tazobactam for > 24 hours prior to screening
- Patient under coercive measures
- 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)
See the full eligibility criteria
- Age ≥ 18 years
- Sepsis (including septic shock) defined according to the Sepsis-3 criteria, 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: a. Invasive mechanical ventilation b. Non-invasive ventilation c. Continuous use of continuous positive airway pressure (CPAP) for hypoxia d. Oxygen supplementation with an oxygen flow of ≥ 10 litres (L)/minute independent of delivery system and total flows e. Continuous infusion of any vasopressor or inotrope (excluding strictly procedure-related infusions)
- Clinical indication for empirical treatment with either meropenem or piperacillin/tazobactam
- Preceding intravenous treatment with meropenem or piperacillin/tazobactam for > 24 hours prior to screening
- Patient under coercive measures
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Saudi Arabia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saudi Arabia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.