Testing Kukoamine B Mesilate for treating sepsis

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

This study is testing a new drug called Kukoamine B Mesilate to see if it can help adults with sepsis feel better and avoid serious complications.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 424 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Tianjin Chasesun Pharmaceutical Co., LTD (industry)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT04803955 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial evaluates the efficacy and safety of Kukoamine B Mesilate in patients diagnosed with sepsis. The study aims to assess the pharmacokinetics of the drug, comparing its effects against a placebo. Participants will be monitored for changes in their condition, specifically focusing on organ failure and infection-related complications. The trial includes adults aged 18 to 85 who meet specific diagnostic criteria for sepsis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with confirmed or suspected sepsis and infection-related organ failure.

Not a fit: Patients who are pregnant, expected to live less than 48 hours, or have poorly controlled end-stage malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients suffering from sepsis, potentially reducing mortality and organ failure rates.

How similar studies have performed: While this approach is novel, similar studies targeting sepsis have shown promise in improving patient outcomes.

Eligibility criteria

Inclusion Criteria:

* (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 Criteria:

* (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.

Where this trial is running

Beijing, Beijing

• Peking Union Medical College Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Shuai Chen, Bachelor

Conditions: Sepsis