Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis

Launched by SCANDINAVIAN CRITICAL CARE TRIALS GROUP · Dec 14, 2023

Keywords

ClinConnect Summary

The EMPRESS trial is studying two commonly used antibiotics, meropenem and piperacillin/tazobactam, to see which one is safer and more effective for adults with sepsis, a serious condition caused by infections that can lead to organ failure. This research is important because many patients in intensive care units receive these antibiotics, but we don’t fully understand how safe they are for people who are critically ill.

To participate in the trial, individuals must be at least 18 years old and have sepsis or septic shock, which means they have a suspected or confirmed infection that has caused a significant decline in their organ function. They also need to be critically ill, often requiring advanced medical support like mechanical ventilation or oxygen therapy. Participants will receive one of the two antibiotics as part of their treatment, and the trial will help doctors learn more about the best options for treating sepsis in critically ill patients. If you or a loved one is considering this trial, it's essential to discuss it with your healthcare provider to understand what it entails and whether it's appropriate.

Gender

ALL

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