Empirical Meropenem versus Piperacillin/Tazobactam for Adult Patients with Sepsis (EMPRESS) trial

Conditions

Sepsis, Septic Shock

Brief summary

All-cause mortality at day 30 after randomisation

Detailed description

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, Number of participants with new isolation precautions due to one or more resistant bacteria within 30 days of randomisation, 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, Days alive and out of hospital from randomisation to day 30, 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 90, Days alive and out of hospital from randomisation to day 90, All-cause mortality at day 90, All-cause mortality at day 180, HRQoL at day 180 using EQ-5D-5L index values, HRQoL at day 180 using EQ VAS

Related papers

No related papers found yet.

Interventions

DRUGMEROPENEM

DRUGPIPERACILLIN AND BETA-LACTAMASE INHIBITOR

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
All-cause mortality at day 30 after randomisation	—

Secondary

Measure	Time frame
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, Number of participants with new isolation precautions due to one or more resistant bacteria within 30 days of randomisation, 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, Days alive and out of hospital from randomisation to day 30, 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 90, Days alive and out of hospital from randomisation to day 90, All-cause mortality at day 90, All-cause mortalit	—

Measure

Time frame

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, Number of participants with new isolation precautions due to one or more resistant bacteria within 30 days of randomisation, 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, Days alive and out of hospital from randomisation to day 30, 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 90, Days alive and out of hospital from randomisation to day 90, All-cause mortality at day 90, All-cause mortalit

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Countries

Denmark

Outcome results

None listed