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

Trial status: Authorised 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 All-cause mortality at day 30 after randomisation

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

Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 700 participants