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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis

Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis (EMPRESS) Trial

Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis (NCT06184659) is a Phase 4 interventional studying Sepsis and Septic Shock, sponsored by Scandinavian Critical Care Trials Group. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 5,800 participants makes this one of the larger Sepsis trials currently registered. Trials at this scale are typically global, run across many sites, and designed to generate the definitive evidence package for an FDA approval submission or a label expansion.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 - willing to sign a consent form following inclusion expected to be unobtainable - Patient under coercive measures Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Meropenem

For meropenem, the standard dose is 1 g administered 3 times daily as a 30-minute intravenous (IV) infusion, and the high dose is 2 g administered 3 times daily by extended 3-hour infusion

DRUG

Piperacillin/Tazobactam

Standard dose of piperacillin/tazobactam 4/0.5 g administered 4 times daily as a 30-minute intravenous (IV) infusion or 3 times daily by extended 4-hour infusions and the recommended high dose is 4/0.5 g administered 4 times daily by extended 3-hour infusion

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Rigshospitalet
Copenhagen, København Ø, Denmark
Rigshospitalet
Copenhagen, Denmark

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06184659), the sponsor (Scandinavian Critical Care Trials Group), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06184659 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06184659?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06184659?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT06184659. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06184659. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.