RecruitingPhase 2NCT04803955

Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients

Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients: a Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Trial

Sponsor

Tianjin Chasesun Pharmaceutical Co., LTD

Enrollment

424 participants

Start Date

May 15, 2021

Study Type

INTERVENTIONAL

Conditions

Sepsis

Summary

Phase II study of Kukoamine B Mesilate in Sepsis Patients

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

(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.

Exclusion Criteria18

(1) Pregnancy or lactation women；
(2) Patients are expected to live less than 48 hours;
(3) Patients had poor control of malignant tumor, end-stage lung disease and other end-stage diseases, or had acardiac arrest，acute pulmonary embolism，blood transfusion response and acute coronary syndrome within 4 weeks prior to enrollment;
(4) The patient has the following chronic organ dysfunction or immunosuppression (based on the chronic health scoring assessment of the APACHE II score) : 1) heart: New York heart association cardiac function IV; 2) breathing: chronic obstructive, obstructive, or vascular lung disease can lead to severe restrictions on activities, i.e. the inability to go upstairs or to do housework; Or clear chronic hypoxia, CO2 retention, secondary real erythrocyte, severe pulmonary hypertension (mPAP> 40 mmHg) or respiratory muscle dependence; 3) kidneys: receiving long-term dialysis; 4) liver: liver cirrhosis confirmed by biopsy and clear portal hypertension; The upper digestive tract hemorrhage caused by portal hypertension; Or previous liver failure/hepatic encephalopathy/hepatic coma; 5) of immune function: accept the treatment of impact resistance to infection, such as immune suppression therapy, chemotherapy, radiotherapy or chemotherapy within 6 months, long-term (continuous use ≥3 weeks) use of glucocorticoids or recent (within 5 days before screening) cumulative use of prednisone or equivalent dose ≥100mg , or sickness impact resistance to infection, such as leukemia, lymphoma and AIDS);
(5) Previous solid organ or bone marrow transplantation;
(6) Plant survival status;
(7) Confirmed or highly suspected of acute infectious diseases such as viral hepatitis activity , or clinically confirmed active tuberculosis;
(8) Patients with sinus bradycardia (less than 60 per minute);
(9) Uncontrolled bleeding in the past 24 hours（Clinical judgment requires transfusion support）;
(10) Large area burns or chemical burns (III degree burns area > 30% BSA);
(11) The average arterial pressure was < 65 mmHg after adequate liquid resuscitation and vasoactive drug therapy;
(12) Acute myeloid hematopoiesis was characterized by a lack of severe granulocytes (ANC < 500 / mm3);
(13) Allergic to the active ingredient or its auxiliary materials;
(14) The medication patients are using may severely affect the metabolism of the drug;
(15) Patients and (or) guardians have signed a Do Not Rescue (DNR), or decided to withdraw life support (withdraw) or restrict life support for the intensity (withhold) and sign the informed consent form;
(16) Participated in clinical intervention test in 3 months;
(17) The subject is a researcher or his immediate family member, or may have improper informed consent;
(18) The investigator considers it inappropriate for the patient to participate in this test.