A Double Blind, Randomized, Placebo Controlled, Multi-Center, Two-Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of Thymosin Î±-1 (TÎ±1) as an add-on Treatment to Existing Standard of Care Treatment in Sepsis Patients.

Gufic Biosciences Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

暂无简介。

•1.Male/female of >= 18 years of age at the time of consent
•2. Patient / Legally Acceptable Representative who can and willing to provide Informed Consent
•3. Patient diagnosed with sepsis according to the sepsis diagnosis criteria of Surviving Sepsis Campaign: International Guidelines for Management of Sepsis 3 and Septic Shock: 2016
•4. Patient with total SOFA scores >=2 (Reports within last 24 hours to be considered for screening. In case of multiple reports, latest one should be considered.)
•5. Patient with confirmed or suspected infection and satisfy at least one of the following: a. Pathogenic microbes grow in blood and at aseptic locations b. Presence of abscess or partially infected tissues c. Suspected infection identified by at least one of the following evidence Leukocytes at normal aseptic locations - Organic perforation (confirmed by imaging evidence, examination result or intestinal content leak during drainage) - Imaging evidence of pneumonia accompanied by purulent secretion
•- Related syndromes with high infection risk (cholangitis for example)
•6. Patient/ patientâ??s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements

•1.Patient Ë? 18 years of age
•2. Patient in need for immediate surgery
•3. Patient with history of organ or bone marrow transplantation
•4. Patient not expected to survive 28 days given their preexisting uncorrectable medical condition
•5. Female patient who is breast-feeding or pregnant
•6. Patient who has participated in another trial with an investigational drug within 1 month prior to this trial.
•7. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.

发起方