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
Conditions
Interventions
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
Sponsors
CERENIS THERAPEUTICS
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Patients weighing more than 100 kg; 2. Alanine transaminase/aspartate transaminase (ALT/AST) > 5 times the upper limit of normal; 3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30 ml /min/1.73 m2); 4. Patients who have AKI and have received nephrotoxic drugs since hospital admission that are known to cause acute tubular necrosis (e.g., vancomycin, aminoglycosides, IV immunoglobulin, mannitol), or with a history of hypovolemic conditions (vomiting, diarrhea, bleeding). 5. Leukocytes<2.0×10^9; 6. Pregnancy or breast feeding; 7. Undergone organ transplantation during the past one year; 8. Anticipated transfer to another hospital, which is not a study site within 72 hours; 9. Terminally ill, including metastases or hematological malignancy, with a life expectancy less than 30 days (as assessed by the attending physician) or have been classified as "Do Not Resuscitate"; 10. Previous history of end stage chronic organ failure(s); 11. Diagnosed with HIV; 12. Uncontrolled hemorrhage within the last 24 h; 13. History of drug hypersensitivity, including history of adverse reactions to radiocontrast agents. 14. Patients who have used an investigational drug or device within 30 days of the first dose of CER-001.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;Secondary Objective: - providing new potential strategy to treat septic patients; - reducing the inflammatory response and preventing the progression to AKI.;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).;Timepoint(s) of evaluation of this end point: 30 days from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactServizio Regolatorio
Consorzio per Valutazioni Biologiche e Farmacologiche
Outcome results
None listed