2024-516780-93-00招募中3 期
Prevention of secondary infections by interferon gamma in ICU-acquired sustained immune-suppression: a randomized trial
Centre Hospitalier Et Universitaire De Limoges23 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2025年7月9日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 326
- 试验地点
- 23
- 主要终点
- Incidence of secondary infection episodes at three months (Day 90) validated by an independent adjudication committee based on the current standardized definitions (CDC surveillance definitions, January 2024)
研究概览
简要总结
To demonstrate the benefit of a standardized immunotherapy with IFN-γ versus placebo on the incidence of secondary infections at three months (Day 90) in ICU patients with documented sustained immunosuppression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient hospitalized in the ICU for at least 1 week
- •Expected length of stay in the ICU greater than 10 days at screening
- •At least 1 episode of multiple organ failure, defined as a SOFA ≥ 6 (excluding the respiratory component when related to a neurological failure), during the first 1 week of ICU hospitalization
- •Immunosuppression defined as an mHLA-DR < 8000 Ab/c and a lymphopenia < 1000/mm3 within a 96 hours time window
- •Patient or the legal representative giving consent must be able to understand the trial in its entirety
- •Patient affiliated to the social security system
- •For female participants of childbearing potential, agreement to use dual methods of contraception until Day 90
- •For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 90.
排除标准
- •Uncontrolled secondary infections ongoing at the time of screening
- •Participation in another research clinical trial within 30 days
- •Chemotherapy / radiation therapy within the last 6 weeks
- •Apache II ≥ 30 at screening
- •History of autoimmune disease
- •Organ or bone marrow transplant
- •History of hematologic malignancy
- •History of hepatitis C
- •HIV stage C within the last 12 months
- •Patients under legal protection
- •History of or ongoing tuberculosis
- •Chronic hepatitis B
- •Patients receiving immunosuppressive medications including patient receiving a steroid dose greater than 1mg/kg/day of prednisone equivalent for more than 1 week and patient that have been on corticosteroid for more than 3 months
- •Patient with thrombocytopenia below 50,000/mm3
- •Patient with traumatic brain and spinal injury
- •Pregnancy or breast feeding
- •Subjects with a history hypersensitivity to interferon gamma or excipient (Mannitol, Sodium succinate dibasic hexahydrate, Succinic acid, polysorbate 20), known latex hypersensitivity or other interferon
- •Hepatic cytolysis with AST/ALT > 5 times ULN (local laboratory)
- •Suspected acute pancreatitis with lipase or amylase > 3 times ULN (local laboratory)
- •Severe chronic renal failure (eGFR<10 ml/min/1.73m2 CKP-EPI method)
- •Acute ECG abnormality such as myocardial infarction or any acute life-threatening ECG abnormalities (e.g: ventricular fibrillation, ventricular tachycardia…)
- •Mental state rendering the person giving consent incapable of understanding the trial
- •Patient deprived of liberty by judicial or administrative decision
- •Patient being the investigator, or any member of the team or relative of the investigator directly involved in the trial, including assistant doctors, pharmacists, nurses, trial coordinators
结局指标
主要结局
Incidence of secondary infection episodes at three months (Day 90) validated by an independent adjudication committee based on the current standardized definitions (CDC surveillance definitions, January 2024)
Incidence of secondary infection episodes at three months (Day 90) validated by an independent adjudication committee based on the current standardized definitions (CDC surveillance definitions, January 2024)
次要结局
- All-cause ICU mortality and at Day 90
- Length of stay in the ICU and in the hospital at Day 90
- Antibiotic and antifungal consumption at Day 90
- Percentage of biological immune restoration (defined as an HLA-DR > 13 500 Ab/c [Antibodies bound per cell] and an absolute lymphocyte count > 1200 mm3) at Day 10
- Healthcare costs at Day 90, cost per secondary infection avoided and cost per additional survivor, isolation requirement and antibiotic resistance
- Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR) at D90
研究者
Bruno FRANCOIS
Scientific
Centre Hospitalier Et Universitaire De Limoges
研究点 (23)
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