EUCTR2014-002479-28-DE进行中（未招募）1 期
GM-CSF Inhalation to improve HOst defense and Pulmonary barrier rEstoration - GI-HOPE
Justus-Liebig University0 个研究点目标入组 45 人开始时间: 2015年4月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All of the following inclusion criteria must be met before the patient can enter into the trial:
- •1. Signed informed consent form by the patient or a legal representative according to local regulations
- •2. Man or woman 18 to 75 years of age, inclusive
- •3. Women who have been post-menopausal for more than 1 year or women of childbearing potential using a highly efficient method of contraception (i.e. a method with less than 1% failure rate such as combined hormonal contraception, progesterone-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tube occlusion, vasectomized partner, sexual abstinence) during dosing and hospitalisation. Women must have a negative serum or urine pregnancy test before the first dose of study medication and must not be lactating.
- •4. Diagnosis of pneumonia-associated ARDS where the underlying condition is Community-Acquired Pneumonia (CAP) or Hospital-Acquired Pneumonia (HAP) in patients not on invasive ventilation upon diagnosis of HAP
- •5. Diagnosis of ARDS according to the Berlin ARDS definition (The ARDS definition task force) as evidenced by:
- •a. onset within 1 week of a known clinical insult or new or worsening respiratory symptoms
- •b. bilateral opacities on chest imaging, in the investigator’s opinion not fully explained by
- •effusions, lobar/lung collapse, or nodules,
- •c. respiratory failure in the investigator’s opinion not fully explained by cardiac failure or fluid
- •d. PaO2/FIO2 =300 mmHg with PEEP =5 cm H2O
- •6. Requirement for positive pressure ventilation (non-invasive or via endotracheal tube) for more than 72 hours in total with FiO2 = 50% (or less when on additional ECMO) not longer than 14 days
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1. Receiving vasopressors of >100 µg/min
- •2. History of liver cirrhosis Child Pugh C, chronic hemodialysis (before severe pneumonia/ARDS), lung cancer
- •3. Malignancy with expected survival time of less than 6 months
- •4. History of, or listing for lung transplantation
- •5. Highly immunosuppressive therapy or anti-malignant combination chemotherapy within 3 weeks prior to first dose of study drug
- •6. Any anti-malignant chemotherapy within 24 hours prior to first dose of study drug
- •7. AIDS or known history of HIV infection
- •8. Pregnancy
- •9. Autoimmune thrombocytopenia, myelodysplastic syndromes with > 20% marrow blast cells
- •10. History or presence of hypersensitivity or idiosyncratic reaction to molgramostim or to related compounds (i.e., Growgen®, Leucomax®, Leukine™, Topleucon™)
- •11. Participation in another clinical trial within 90 days prior to the first dose of study drug
研究者
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