MEROPENEM ANHYDROUS for Infection | Sepsis

Inclusion criteria

• {"criterion_text":"- Written informed consent\n- Adult (≥ 18 years) patients of both sexes.\n- Suspicion of infection defined as the presence of at least one of: Fever defined as core temperature ≥380 C , Tachycardia defined as more than 90 heart beats/min ,Acute presence of any of: shortness of breath or dysuria, or diarrhea or abdominal pain,Complaints that according to investigator’s discretion indicate/are correlated with the presence of infection\n- Presence of either a) one of qSOFA signs (mental confusion, systolic blood pressure less than 100mmHg, respiratory rate more than 22 breaths/min) OR b) NEWS2 equal to 5 or 6 (see Appendices I and II). It is explicitly stated that patients with 0 qSOFA signs may be enrolled in the study if the NEWS2 is 5 or 6. It is also explicitly stated that patients with NEWS2 less than 5 may be enrolled in the study if qSOFA is equal to one.\n- PSP ≥300ng/ml"}

Exclusion criteria

• {"criterion_text":"- Deny to consent\n- Documented acute organ dysfunction compatible with sepsis, as reflected by an increase in SOFA-2 score by ≥2 points.\n- Age less than 18 years\n- Patients with nil signs of qSOFA\n- Patients with two or three qSOFA signs\n- Pregnancy (confirmed by blood or urinary pregnancy test that will be conducted after the signing of the consent form at the emergency department) for female patients of reproductive age or lactation\n- NEWS2 ≥ 7\n- Full-blown sepsis with overt organ dysfunction (defined as need of high flow oxygen or mechanical ventilation or vasopressors)\n- Hypersensitivity to meropenem, or to any other antibacterial agent that includes meropenem. Severe hypersensitivity to any antibacterial agent belonging to beta lactam class (eg. penicillins or cephalosporins).\n- Patients receiving probenecid, valproic acid or warfarin."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of this study is 28-day mortality, defined as death from any cause occurring within 28 days after randomization. The aim is to evaluate if early administration of antibiotics guided by early sepsis detection with the device under investigation is associated with a reduction in short-term mortality compared to the control group. Survival is censored at day 28 since this is globally recognized as the survival censoring point in all sepsis trials.","definition_or_measurement_approach":"Defined as death from any cause occurring within 28 days after randomization; survival is censored at day 28."}

Secondary endpoints

• {"endpoint_text":"- The key secondary endpoint is the progression into organ dysfunction defined as increases of total SOFA-2 score by 2 or more points the first 24 hours.\n- Comparative changes of the total SOFA-2 scores by the first 48 and 96 hours.\n- Time to stop of antibiotics (defined as treatment started at the discretion of the attending physicians)\n- Rate of hospitalization\n- Time to hospital discharge alive\n- 90-day mortality\n- Kinetics of PSP over-time and per type of infection\n- Rate of resistant fecal flora\n- Primary endpoint, key secondary endpoint and all secondary endpoints for patients classified into infections after adjudication","definition_or_measurement_approach":"1) Progression into organ dysfunction: increase of total SOFA-2 score by ≥2 points within first 24 hours. 2) Comparative changes of total SOFA-2 scores measured at 48 and 96 hours. 3) Time to stop of antibiotics: time to discontinuation of antimicrobial therapy started at discretion of attending physicians. 4) Rate of hospitalization: proportion hospitalized. 5) Time to hospital discharge alive: time from randomization to hospital discharge alive. 6) 90-day mortality: death from any cause within 90 days. 7) Kinetics of PSP: serial PSP measurements over time and by infection type. 8) Rate of resistant fecal flora: measurement of antimicrobial resistance in fecal flora. 9) Endpoints re-classified by adjudicated infection type: primary and secondary endpoints assessed within infection categories after adjudication."}

Greece

Earliest CTIS Part Ii Submission Date

06-02-2026

Latest Decision Or Authorization Date

29-04-2026

Processing Time Days

82

Number Of Sites

10

Number Of Participants

398

Primary sponsor

Full Name

Elliniko Institouto Meletis Tis Sipsis

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Greece