A RAndomized pilot study comparing short-term CER-001 infusions at different doses to prevent Sepsis-induced acute kidney injury

INTERVENTION: Product Name: CER‐001 Product Code: [1383435‐67‐3] Pharmaceutical Form: Infusion Current Sponsor code: CER‐001 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 8‐ Product Name: CER‐001 Product Code: [1383435‐67‐3] Pharmaceutical Form: Infusion Current Sponsor code: CER‐001 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 8‐ Product Name: CER‐001 Product Code: [1383435‐67‐3] Pharmaceutical Form: Infusion Current Sponsor code: CER‐001 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 8‐ CONDITION: Sepsis due to intra‐abdominal cavity infection or urosepsis ; MedDRA version: 21.1 Level: LLT Classification code 10073462 Term: Injection site allergic reaction System Organ Class: 100000004867 Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: To investigate whether the use of CER‐001 at different doses in combination with standard of care (SOC) treatment is safe and effective Primary end point(s): The co‐primary end‐points of the study are: 1. Determination of optimal dose of CER‐001 in combination with standard of care based on safety. 2. Onset of AKI according to KDIGO criteria (serum creatinine in the first 6 hours >1.5–1.9 times baseline creatinine and/or urine output < 0.5 ml/kg/h for 6‐12 hours; see Table 2) 3. Severity of AKI according to KDIGO (Stages 1, 2 or 3; see Table 2 for definitions). Secondary Objective: ‐ providing new potential strategy to treat septic patients;; ‐ reducing the inflammatory response and preventing the progression to AKI. Timepoint(s) of evaluation of this end point: 30 days from baseline SECONDARY OUTCOME: Secondary end point(s): Mortality at Day 30; Change in endotoxin and IL‐6 levels from baseline to Day 3, Day 6 and Day 9. Baseline will be defined as the last measurements taken prior to dosing on Day 1.; Change in the SOFA score(47) from baseline to Day 3, Day 6 and Day 9.; Changes to the key inflammatory markers (CRP, D‐dimer, Ferritin, IL‐8, GM‐CSF, MCP 1 and TNF‐a) from baseline to Day 3, Day 6 and Day 9.; Changes in AKI biomarkers. Timepoint(s) of evaluation of this end point: 30 days; Day 3, 6 and 9; Day 3, 6 and 9; Day 3, 6 and 9; 30 days INCLUSION CRITERIA: 1. Male or non‐pregnant female adult =18 years of age at time of enrollment; 2. Patients affected by sepsis sustained by Gram negative bacteria (positive body fluid cultures and/or documented endotoxin activity) on antibiotic treatment 3. Meets Sepsis 3 criteria, defined as an acute increase of at least 2 points in SOFA score relative to the SOFA score upon admission; 4. Endotoxin level (EEA™) >0.6; 5. Signed and dated informed consent by the patient itself or by a legal representative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10