Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis

• Status: Not yet recruiting
• Trial end date: 2029-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scandinavian Critical Care Trials Group
• Treatments: Meropenem; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

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