Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT06184659
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06184659
Study Brief:
Protocol Section:
NCT06184659