NCT06184659 Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis
| NCT ID | NCT06184659 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Scandinavian Critical Care Trials Group |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,800 participants |
| Start Date | 2025-06-26 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 5,800 participants in total. It began in 2025-06-26 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 drugs is unclear in this group of patients.
Eligibility Criteria
Inclusion Criteria: * 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: 1. Invasive mechanical ventilation 2. Non-invasive ventilation 3. Continuous use of continuous positive airway pressure (CPAP) for hypoxia 4. Oxygen supplementation with an oxygen flow of ≥ 10 litres (L)/minute independent of delivery system and total flows 5. Continuous infusion of any vasopressor or inotrope (excluding strictly procedure-related infusions) * Clinical indication for empirical treatment with either meropenem or piperacillin/tazobactam Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06184659 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06184659 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06184659 currently recruiting?
Yes, NCT06184659 is actively recruiting participants. Contact the research team at morten.hylander.moeller@regionh.dk for enrollment information.
Where is the NCT06184659 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Copenhagen, Denmark.
Who is sponsoring the NCT06184659 clinical trial?
NCT06184659 is sponsored by Scandinavian Critical Care Trials Group. The trial plans to enroll 5,800 participants.