NCT00697944Unknown4 期
Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis
Fovea4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects
研究概览
简要总结
To assess the safety of Ambisome 10 mg/kg/week in patients as a preemptive treatment in intensive care patients with a sepsis and rising candida colonisation.
Preemptive treatment (i.e., prophylactic treatment with two high doses of Ambisome® administered with an interval of one week, in patiens with a high risk of developing a fungal infection) should decrease the incidence of actual systemic infections.
The incidence of such actual fungal infections will be assessed directly and its impact on patients' survival and intensive care resourches assessed
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Supportive mechanical ventilation for more than 48 h
- •LOD > 5 with with ailing body systems
- •Candida colonisation of at least one site in addition to the digestive tract
- •Suspected nosocomial infection with antibiotic treatment
- •Informed consent
排除标准
- •Patients treated with oral or systemic antifungal agents within 15 days prior to inclusion
- •Patients requiring treatment with an antifungal agent or with a documented (proven or probable) fungal infection according to the EORTC criteria
- •Patients with a SAPS score > 65
- •Patients with neutropenia of that underwent a bone marrow tar organ transplant or with cancer chemotherapy
- •Blood creatinine > 220 µmol/L
- •Hemodyalysis
- •Pregnant women
结局指标
主要结局
Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects
时间窗: 28-day observation period
次要结局
- Duration of stay in the intensive care unit; occurrence of a systemic fungal infection(28 days after first treatment administration)
研究者
研究点 (4)
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