Meropenem versus piperacillin/tazobactam for adults with sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

EMPRESS is an international, investigator-initiated, randomized, open-label adaptive trial comparing empirical meropenem with piperacillin/tazobactam in critically ill adults meeting Sepsis-3 criteria. It uses response-adaptive randomisation and adaptive stopping rules with an integrated feasibility phase to make the trial more likely to reach clear conclusions and to increase patients' chances of receiving the better-performing antibiotic. The primary focus is on mortality and other patient-important outcomes during critical care, with participants enrolled when clinicians plan empirical treatment with either study antibiotic. The trial excludes patients who have already received these antibiotics intravenously for more than 24 hours and other standard contraindications.

Why it matters

Who can join: the full rules

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

Where it's running

• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Rigshospitalet
  Copenhagen, København Ø, Denmark Not yet recruiting

Study contacts

• Study coordinator: Morten H Møller, MD, Professor, PhD
• Email: morten.hylander.moeller@regionh.dk
• Phone: 4535458685

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.