Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis (EMPRESS) Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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:
‣ Invasive mechanical ventilation
⁃ Non-invasive ventilation
⁃ Continuous use of continuous positive airway pressure (CPAP) for hypoxia
⁃ Oxygen supplementation with an oxygen flow of ≥ 10 litres (L)/minute independent of delivery system and total flows
⁃ Continuous infusion of any vasopressor or inotrope (excluding strictly procedure-related infusions)
• Clinical indication for empirical treatment with either meropenem or piperacillin/tazobactam
Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Contact Information
Primary
Morten H Møller, MD, Professor, PhD
morten.hylander.moeller@regionh.dk
4535458685
Backup
Nick Meier, MD
nick.meier@regionh.dk
4535450606
Time Frame
Start Date:2025-06-26
Estimated Completion Date:2029-03-30
Participants
Target number of participants:5800
Treatments
Experimental: Meropenem
Participants in the experimental intervention arm will receive 1 g of IV meropenem three times daily administered according to usual clinical practice (i.e., intermittent-, prolonged-, or continuous infusion) until discharge from the participating site, death, or termination of empirical antibiotic therapy (including initiation of definitive treatment).
Active_comparator: Piperacillin/Tazobactam
Participants in the control arm will receive 4/0.5 g of intravenous piperacillin/tazobactam four times daily administered according to usual clinical practice (i.e., intermittent-, prolonged-, or continuous infusion) until discharge from the participating site, death, or termination of empirical antibiotic therapy (including initiation of definitive treatment).