CTRI/2022/09/045538招募中3 期
A Double Blind, Randomized, Placebo Controlled, Multi-Center, Two-Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of Thymosin α-1 (Tα1) as an add-on Treatment to Existing Standard of Care Treatment in Sepsis Patients.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Change in Sequential Organ Failure Assessment (SOFA) score
研究概览
简要总结
Sepsis is a significant heterogeneous clinical syndrome with the characters of high mortality and incidence. It is a life-threatening organ dysfunction caused by host immune response to infection.
IP is Thymosin alpha 1 (Tα1), acting as an immune modulator, exerts great biological influence in activating and restoring the dysregulated immune response for patients with sepsis
Total 120 eligible patients will be enrolled in 1:1 ratio in two treatment arms (60 patients in each arm).
7 days of treatment and follow up on Day 28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male/female of ≥ 18 years of age at the time of consent
- •Patient / Legally Acceptable Representative who can and willing to provide Informed Consent
- •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"
- •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.)
- •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)
- •Patient/ patient’s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements.
排除标准
- •1.Patient Ë‚ 18 years of age
- •Patient in need for immediate surgery
- •Patient with history of organ or bone marrow transplantation
- •Patient not expected to survive 28 days given their preexisting uncorrectable medical condition
- •Female patient who is breast-feeding or pregnant
- •Patient who has participated in another trial with an investigational drug within 1 month prior to this trial.
- •Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
结局指标
主要结局
Change in Sequential Organ Failure Assessment (SOFA) score
时间窗: from Screening/ Baseline (Day 1) and End of treatment ( Day 7)
次要结局
- ICU-free days(time frame28 days)
- Continuous Renal Replacement Therapy (CRRT) free days(Time frame 28 days)
- Vasoactive agents-free days(Time frame 28 days)
- Incidence of emerging infection within 7 days(from Screening/ Baseline (Day 1) and End of treatment ( Day 7))
- Clearance rate of pathogenic microorganism over a period of 7-days(from Screening/ Baseline (Day 1) and End of treatment ( Day 7))
- Duration of hospitalization(Day 28)
- Ventilator-free days(time frame 28 days)
- Change in Absolute Lymphocyte count from Screening/ Baseline (Day 1) and End of Treatment(Screening/ Baseline (Day 1) and End of treatment ( Day 7))
- Change in CD4/CD8 ratio(Screening/ Baseline (Day 1) and End of treatment ( Day 7))
- Change in Neutrophil-lymphocyte (NLR) ratio(Screening/ Baseline (Day 1) and End of treatment ( Day 7))
- Change in Tumour Necrosis Factor (TNF) levels(Screening/ Baseline (Day 1) and End of treatment ( Day 7))
- Change in C-Reactive Protein (CRP) levels(Screening/ Baseline (Day 1) and End of treatment ( Day 7))
- Change in serum lactate levels only in suspected patients with septic shock.(Screening/ Baseline (Day 1) and End of Treatment (Day 7))
- Number of days without antibiotics(Time Frame: 28 days)
- Incidences of all-cause hospital mortality(From date of Drug administered until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 28 days])
- Number of Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event(Time frame 28 days)
研究者
研究点 (10)
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