SepsisPhase 4EMPRESSNCT06184659
Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis
A Phase 4 study testing Meropenem and Piperacillin/Tazobactam in people with Sepsis and Septic Shock, run by Scandinavian Critical Care Trials Group at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Meropenem and Piperacillin/Tazobactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,800 participants
- Where
- 2 sitesDenmark
- Study dates
- 26 Jun 2025to 30 Mar 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Rigshospitalet
Copenhagen, København Ø, 2100
Morten H Moeller, MD, Professor, PhD, 4535458685, morten.hylander.moeller@regionh.dk
Nick Meier, MD, 4535450606, nick.meier@regionh.dk
- Recruiting
Rigshospitalet
Copenhagen
Morten H Møller, Professor, +4535450606, empress@cric.nu
Morten H Moeller
About this study
Official title: Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis (EMPRESS) 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.
Read the detailed description
Background Piperacillin/tazobactam and meropenem are commonly used as empirical agents for patients with sepsis or septic shock. In a recent systematic review comparing empirical and/or definitive treatment with piperacillin/tazobactam versus meropenem for patients with severe bacterial infections, including sepsis and septic shock, it was shown that piperacillin/tazobactam may be associated with less favourable outcomes based on low or very low certainty of evidence. At present, it is unclear if piperacillin/tazobactam and meropenem are equally effective and safe for adults with sepsis.
Objectives To assess the effects of empirical meropenem vs. piperacillin/tazobactam on mortality and other patient-important outcomes in critically ill adults with sepsis.
Design Investigator-initiated, international, parallel-group, randomised, open-label, adaptive clinical trial with an integrated feasibility phase. The EMPRESS trial will employ adaptive stopping rules to increase the chance that the trial will be conclusive and response-adaptive randomisation to increase each participant's chance of being randomised to the superior intervention arm.
Inclusion and exclusion criteria We will screen all adult patients who are critically ill with sepsis and who have indication for empirical treatment with meropenem or piperacillin/tazobactam. We will exclude patients with preceding intravenous treatment with meropenem or piperacillin/tazobactam for 24 hours or more; known pregnancy; known hypersensitivity or allergy to beta-lactam antibiotics; suspected or documented central nervous system infection; known infection or colonialisation with microorganism with acquired resistance to meropenem or piperacillin/tazobactam; current use of valproate; co-enrolment in other interventional trial where protocols collide; previous randomisation in EMPRESS; informed consent following inclusion expected to be unobtainable; and patients who are under coercive measures.
Experimental intervention IV meropenem 1 g three times daily for up to 30 days.
Control intervention IV piperacillin/tazobactam 4/0.5 g four times daily for up to 30 days.
Outcomes The primary outcome is all-cause mortality at 30 days after randomisation. The secondary outcomes are the occurrence at least one serious adverse reaction (i.e., anaphylactic reaction to IV piperacillin/tazobactam or meropenem, invasive fungal infection, pseudomembranous colitis, or toxic epidermal necrolysis) within 30 days of randomisation; the occurrence of new isolation precautions due to resistant bacteria within 30 days of randomisation; days alive without life support (i.e., invasive mechanical ventilation, circulatory support, or renal replacement therapy) from randomisation to day 30 and 90; days alive and out of hospital from randomisation to day 30 and 90; all-cause mortality at day 90 and 180; and health-related quality of life at day 180 using EQ-5D-5L index values and EQ VAS. The feasibility outcomes are time to completion of feasibility phase (i.e., 200 participants randomised), recruitment proportion, proportion of participants without consent to the use of data, protocol adherence, and retention proportion.
Statistics and stopping rules The trial will be analysed using Bayesian statistical methods with the primary analyses conducted in the intention-to-treat population. Outcomes will be analysed using logistic and linear regression models adjusted for relevant baseline characteristics and neutral and weakly informative to somewhat sceptical priors. Results will be presented as adjusted sample average treatment effects using both absolute (risk and mean differences) and relative (risk ratios and ratios of means) differences with 95% credible intervals and probabilities of benefit/harm. Adaptive analyses will start after follow-up and data collection concludes for 400 participants and every subsequent 300 participants up to a maximum of 14,000 participants. Adaptations will be based on data for the primary outcome. EMPRESS will use constant, symmetrical stopping rules for inferiority/superiority calibrated to keep the type 1 error rate at 5%. Further, the trial will be stopped for practical equivalence if there is 90% probability that the absolute risk difference between arms is less than 2.5%-points. Restricted response-adaptive randomisation will be used to ensure minimum allocation probabilities of 40% to both groups.
Missing data will be imputed, and relevant secondary analyses, sensitivity analyses, and analyses of heterogeneity in treatment effects according to pre-defined baseline characteristics will be undertaken once the trial has been stopped.
Trial design performance metrics Performance characteristics were evaluated assuming a 25% event probability for the primary outcome in the piperacillin/tazobactam arm and scenarios with no, small, and large differences corresponding to event probabilities of 25%, 22.5%, and 20% in the meropenem arm, respectively. The expected (mean) sample sizes under these scenarios are 5189, 5859, and 2570, respectively. The probabilities of conclusiveness (i.e., superiority or equivalence) are 99% in all scenarios, and the probabilities of superiority (power) are 72% and \& 99% in the small and large difference scenarios, respectively.
Estimated timeline
- Primo 2024: authority approvals and first participant randomised
- Primo 2025: feasibility phase analysis concluded
- Medio 2028: expected inclusion of the last participant if trial continues to the expected sample size in the small-difference scenario (i.e., the largest expected sample size under the three different scenarios assessed) (section 19.9)
- Medio 2032: expected inclusion of the last participant if the trial continues to the maximum sample size (n=14,000) (section 19.9)
- Approximately 3 months after inclusion of the last participant: primary report on 30-day outcomes submitted
- Approximately 6 months after inclusion of the last participant: report on 90-day outcomes submitted
- Approximately 9 months after inclusion of the last participant: report on 180-day outcomes submitted
- Conditions
- Sepsis, Septic Shock
- Being tested
- Meropenem, Piperacillin/Tazobactam
- Keywords
- Sepsis, Septic Shock, Intensive Care, Antimicrobial therapy, Meropenem, Piperacillin/Tazobactam
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropenemDrug
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
Piperacillin/TazobactamDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Meropenem | Experimental | 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). Receives: Drug: Meropenem |
| Piperacillin/Tazobactam | Active comparator | 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). Receives: Drug: Piperacillin/Tazobactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Number of participant deaths from all causes at day 30 after randomisation.
Measured: Baseline to 30 days after enrollment
Secondary outcomes (6)
Serious Adverse Reaction (SAR)
Number of participants with one or more serious adverse reactions (SARs, defined as anaphylactic shock to IV piperacillin/tazobactam or meropenem, invasive fungal infection, pseudomembranous colitis, or toxic epidermal necrolysis) within 30 days of randomisation.
Measured: Baseline to 30 days after enrollment
Bacterial resistance
Number of participants with new isolation precautions due to one or more resistant bacteria within 30 days of randomisation.
Measured: Baseline to 30 days after enrollment
Days alive without life support
Days alive without life support (i.e., invasive mechanical ventilation, circulatory support, or renal replacement therapy [including days in between intermittent renal replacement therapy]) from randomisation to day 30 and 90.
Measured: Baseline to day 30 and day 90 after enrollment
Days alive and out of hospital
Days alive and out of hospital from randomisation to day 30 and 90.
Measured: Day 30 and day 90 after enrollment
All-cause mortality
Number of participant deaths from any cause at day 90 and 180.
Measured: Day 90 and day 180 after enrollment
Health-related Quality of Life (HRQoL)
HRQoL at day 180 using the 5-level EQ-5D version (EQ-5D-5L) index values (ranging from 0 to 100, where 0 represents the worst health you can imagine and 100 represents the best health you can imagine).
Measured: Day 180 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start26 Jun 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scandinavian Critical Care Trials Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184659
- Sponsor's protocol ID
- RH-ITA-010
- Other IDs
- 2023-509703-33-00, 2023
- Acronym
- EMPRESS
- Status last verified
- Jun 2025
- First submitted
- 14 Dec 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymised version of the final dataset (without personal, identifiable information, with timestamps replaced by relative time differences with respect to the time of randomisation, and other measures as deemed relevant) may be shared with other researchers following a reasonable request (i.e., a research proposal outlining the objectives, methodologies, and plans for data usage) and subsequent approval by the EMPRESS Management Committee. Any sharing of data that is not considered anonymised will be after the necessary approvals; alternatively, aggregation, scrambling, or synthetic datasets (101) (i.e., datasets with similar structure and attempts to preserve the overall relationships between variables as the original dataset) may be shared. Data will generally only be shared after a grace period of at least 9 months following initial publication of results based on the data. Approved researchers will sign appropriate agreements to ensure compliance.
Publications
Meier NF, Moller MH, Kjaer MN, Sjovall F, Munch MW, Kaas-Hansen BS, Thorsen-Meyer HC, Rasmussen BS, Helleberg M, Hertz FB, Lange T, Jensen AKG, Andersen LW, Andersen JS, Michelsen J, Andersen LPK, Bestle MH, Brochner AC, Itenov TS, Christensen S, Plovsing RTR, Koch KU, Moller A, Schjorring OL, Crano NB, Vamdrup-Andersen K, Placido D, Meyhoff TS, Anthon CT, Togern A, Grigonyte-Daraskeviciene M, Engbakken Z, Kamstrup AW, Uhre KR, Barakji JA, Larsen RF, Perner A, Granholm A. Empirical Meropenem Versus Piperacillin/Tazobactam for Critically Ill Adults With Sepsis: Feasibility of a Randomised Trial. Acta Anaesthesiol Scand. 2026 Oct;70(9):e70324. doi: 10.1111/aas.70324.
PubMed 42674465
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis (EMPRESS) Trial
- ClinicalTrials.gov ID
- NCT06184659
- Acronym / sponsor ID
- EMPRESS / RH-ITA-010
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Septic Shock, Intensive Care, Antimicrobial therapy, Meropenem, Piperacillin/Tazobactam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,800 participants (estimated)
- Lead sponsor
- Scandinavian Critical Care Trials GroupUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background Piperacillin/tazobactam and meropenem are commonly used as empirical agents for patients with sepsis or septic shock. In a recent systematic review comparing empirical and/or definitive treatment with piperacillin/tazobactam versus meropenem for patients with severe bacterial infections, including sepsis and septic shock, it was shown that piperacillin/tazobactam may be associated with less favourable outcomes based on low or very low certainty of evidence. At present, it is unclear if piperacillin/tazobactam and meropenem are equally effective and safe for adults with sepsis.
Objectives To assess the effects of empirical meropenem vs. piperacillin/tazobactam on mortality and other patient-important outcomes in critically ill adults with sepsis.
Design Investigator-initiated, international, parallel-group, randomised, open-label, adaptive clinical trial with an integrated feasibility phase. The EMPRESS trial will employ adaptive stopping rules to increase the chance that the trial will be conclusive and response-adaptive randomisation to increase each participant's chance of being randomised to the superior intervention arm.
Inclusion and exclusion criteria We will screen all adult patients who are critically ill with sepsis and who have indication for empirical treatment with meropenem or piperacillin/tazobactam. We will exclude patients with preceding intravenous treatment with meropenem or piperacillin/tazobactam for 24 hours or more; known pregnancy; known hypersensitivity or allergy to beta-lactam antibiotics; suspected or documented central nervous system infection; known infection or colonialisation with microorganism with acquired resistance to meropenem or piperacillin/tazobactam; current use of valproate; co-enrolment in other interventional trial where protocols collide; previous randomisation in EMPRESS; informed consent following inclusion expected to be unobtainable; and patients who are under coercive measures.
Experimental intervention IV meropenem 1 g three times daily for up to 30 days.
Control intervention IV piperacillin/tazobactam 4/0.5 g four times daily for up to 30 days.
Outcomes The primary outcome is all-cause mortality at 30 days after randomisation. The secondary outcomes are the occurrence at least one serious adverse reaction (i.e., anaphylactic reaction to IV piperacillin/tazobactam or meropenem, invasive fungal infection, pseudomembranous colitis, or toxic epidermal necrolysis) within 30 days of randomisation; the occurrence of new isolation precautions due to resistant bacteria within 30 days of randomisation; days alive without life support (i.e., invasive mechanical ventilation, circulatory support, or renal replacement therapy) from randomisation to day 30 and 90; days alive and out of hospital from randomisation to day 30 and 90; all-cause mortality at day 90 and 180; and health-related quality of life at day 180 using EQ-5D-5L index values and EQ VAS. The feasibility outcomes are time to completion of feasibility phase (i.e., 200 participants randomised), recruitment proportion, proportion of participants without consent to the use of data, protocol adherence, and retention proportion.
Statistics and stopping rules The trial will be analysed using Bayesian statistical methods with the primary analyses conducted in the intention-to-treat population. Outcomes will be analysed using logistic and linear regression models adjusted for relevant baseline characteristics and neutral and weakly informative to somewhat sceptical priors. Results will be presented as adjusted sample average treatment effects using both absolute (risk and mean differences) and relative (risk ratios and ratios of means) differences with 95% credible intervals and probabilities of benefit/harm. Adaptive analyses will start after follow-up and data collection concludes for 400 participants and every subsequent 300 participants up to a maximum of 14,000 participants. Adaptations will be based on data for the primary outcome. EMPRESS will use constant, symmetrical stopping rules for inferiority/superiority calibrated to keep the type 1 error rate at 5%. Further, the trial will be stopped for practical equivalence if there is 90% probability that the absolute risk difference between arms is less than 2.5%-points. Restricted response-adaptive randomisation will be used to ensure minimum allocation probabilities of 40% to both groups.
Missing data will be imputed, and relevant secondary analyses, sensitivity analyses, and analyses of heterogeneity in treatment effects according to pre-defined baseline characteristics will be undertaken once the trial has been stopped.
Trial design performance metrics Performance characteristics were evaluated assuming a 25% event probability for the primary outcome in the piperacillin/tazobactam arm and scenarios with no, small, and large differences corresponding to event probabilities of 25%, 22.5%, and 20% in the meropenem arm, respectively. The expected (mean) sample sizes under these scenarios are 5189, 5859, and 2570, respectively. The probabilities of conclusiveness (i.e., superiority or equivalence) are 99% in all scenarios, and the probabilities of superiority (power) are 72% and \& 99% in the small and large difference scenarios, respectively.
Estimated timeline
- Primo 2024: authority approvals and first participant randomised
- Primo 2025: feasibility phase analysis concluded
- Medio 2028: expected inclusion of the last participant if trial continues to the expected sample size in the small-difference scenario (i.e., the largest expected sample size under the three different scenarios assessed) (section 19.9)
- Medio 2032: expected inclusion of the last participant if the trial continues to the maximum sample size (n=14,000) (section 19.9)
- Approximately 3 months after inclusion of the last participant: primary report on 30-day outcomes submitted
- Approximately 6 months after inclusion of the last participant: report on 90-day outcomes submitted
- Approximately 9 months after inclusion of the last participant: report on 180-day outcomes submitted
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem | Experimental | Drug: MeropenemParticipants 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). |
| Piperacillin/Tazobactam | Active comparator | Drug: Piperacillin/TazobactamParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Clinical indication for empirical treatment with either meropenem or piperacillin/tazobactam
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeropenemFor 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 | Meropenem |
| Piperacillin/TazobactamStandard 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 | Drug | Piperacillin/Tazobactam |
Primary outcome
All-cause mortality
Time frame: Baseline to 30 days after enrollment
Number of participant deaths from all causes at day 30 after randomisation.
6 secondary outcomes
Serious Adverse Reaction (SAR)
Time frame: Baseline to 30 days after enrollment
Bacterial resistance
Time frame: Baseline to 30 days after enrollment
Days alive without life support
Time frame: Baseline to day 30 and day 90 after enrollment
Days alive and out of hospital
Time frame: Day 30 and day 90 after enrollment
All-cause mortality
Time frame: Day 90 and day 180 after enrollment
Health-related Quality of Life (HRQoL)
Time frame: Day 180 after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Derived from this study: PubMed 42674465Meier NF, Moller MH, Kjaer MN, Sjovall F, Munch MW, Kaas-Hansen BS, Thorsen-Meyer HC, Rasmussen BS, Helleberg M, Hertz FB, Lange T, Jensen AKG, Andersen LW, Andersen JS, Michelsen J, Andersen LPK, Bestle MH, Brochner AC, Itenov TS, Christensen S, Plovsing RTR, Koch KU, Moller A, Schjorring OL, Crano NB, Vamdrup-Andersen K, Placido D, Meyhoff TS, Anthon CT, Togern A, Grigonyte-Daraskeviciene M, Engbakken Z, Kamstrup AW, Uhre KR, Barakji JA, Larsen RF, Perner A, Granholm A. Empirical Meropenem Versus Piperacillin/Tazobactam for Critically Ill Adults With Sepsis: Feasibility of a Randomised Trial. Acta Anaesthesiol Scand. 2026 Oct;70(9):e70324. doi: 10.1111/aas.70324.
- Individual participant dataSharing planned: Yes. An anonymised version of the final dataset (without personal, identifiable information, with timestamps replaced by relative time differences with respect to the time of randomisation, and other measures as deemed relevant) may be shared with other researchers following a reasonable request (i.e., a research proposal outlining the objectives, methodologies, and plans for data usage) and subsequent approval by the EMPRESS Management Committee. Any sharing of data that is not considered anonymised will be after the necessary approvals; alternatively, aggregation, scrambling, or synthetic datasets (101) (i.e., datasets with similar structure and attempts to preserve the overall relationships between variables as the original dataset) may be shared. Data will generally only be shared after a grace period of at least 9 months following initial publication of results based on the data. Approved researchers will sign appropriate agreements to ensure compliance.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meropenem and Piperacillin/Tazobactam in people with Sepsis and Septic Shock, run by Scandinavian Critical Care Trials Group at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morten H Møller, MD, Professor, PhD (4535458685, morten.hylander.moeller@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Baseline to 30 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06184659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.