Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients: a Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Trial
Phase II study of Kukoamine B Mesilate in Sepsis Patients
• (1) The age of ≥ 18 years of age and ≤ 85 years of age, gender is not limited;
• (2) Meeting the diagnostic criteria for sepsis 3.0, i.e. sequential organ failure score (SOFA) increased by ≥2 points from baseline for patients with confirmed or suspected infection;
• (3) Confirmed or suspected bacterial infection (Pulmonary, abdominal，urinary system or hematogenous infections);
• (4) Infection-related organ failure does not exceed 48 hours; organ failure is defined as circulation, (SOFA) ≥ 3 points in at least one organ or system of the respiratory, kidney, liver, coagulation and central nervous system;
• (5) Childbearing age within six months without child care plan and agreed to take effective measures during the study of contraception;
• (6) Patients or guardians signed informed consent.