EUCTR2018-003117-18-ES进行中（未招募）1 期
A phase III randomized, controlled, open label multicenter clinical trial, with two parallel groups, to evaluate the efficacy of albumin administration in patients hospitalized with community-acquired pneumonia (ALBUCAP)
Dr. Jordi Carratalà Fernández (Servicio de Enfermedades Infecciosas) del Hospital Universitario de Bellvitge0 个研究点目标入组 360 人开始时间: 2019年4月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
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
- •1) Adult patients (18 years or older), of both genders, hospitalized for CAP
- •2) Patients with a hypoalbuminemia (serum albumin =30 g/L)
- •3)Subjects, their legal representative or closest familiar (in case of incapacity of the subject due to the seriousness of the clinical situation: patients hospitalized in ICU, delirium) otorgates the informed consent.
- •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 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 216
排除标准
- •1) Pregnancy and/or breastfeeding. If a subject is a female of childbearing potential, she must have a negative result on an approved urine pregnancy test at the time of screening.
- •2) Severe immunosuppressed patients (e.g. chemotherapy or radiotherapy in the previous 90 days, receiving immunosuppressants, chronic use of corticosteroids at a minimum dose of 15 mg/day in the last two weeks, transplantation of hematopoietic progenitors, solid organ transplantation, HIV patients with CD4 less than 200)
- •3) Imminent death
- •4) Congestive heart failure (NYHA class 3 or 4)
- •5) Known adverse reactions to albumin or some of its excipients
- •6) Conditions in which there is another indication for the administration of albumin (e.g. liver cirrhosis with ascites, malabsorption syndrome, nephrotic syndrome)
- •7) Participation in another clinical trial in the three previous months.
研究者
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