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Recruiting Phase 4 NCT06184659

Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis

Trial Parameters

Condition Sepsis
Sponsor Scandinavian Critical Care Trials Group
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 5,800
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-06-26
Completion 2028-06-30
Interventions
MeropenemPiperacillin/Tazobactam

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 preg

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