SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 41
- 主要终点
- Incidence of Invasive fungal infections
研究概览
简要总结
SEIFEM 2010 study is a prospective, multicenter registry designed to identify and analyze risk factors for developing an invasive fungal infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest on pre-hospital risk factors (i.e. those related to normal activities of daily life, such as occupation, location and type of residence, consume of tobacco, alcohol and others).
详细描述
SEIFEM 2010:
EPIDEMIOLOGICAL SURVEY ON POSSIBLE PRE-HOSPITAL RISK FACTORS FOR DEVELOPING INVASIVE FUNGAL INFECTIONS IN PATIENTS AFFECTED BY ACUTE MYELOID LEUKEMIA
Background:
In two different multicenter surveys conducted in Italy from 1988-1997 and 1999-2003, (Invasive Fungal Infections) IFIs were found to be a frequent cause of morbidity and mortality in patients treated with conventional chemotherapies, particularly in those suffering from acute myeloid leukemia (AML).
In general, the major factors that have been recognized as influencing the likelihood of invasive fungal infection are the patient's immune status, the degree of any organ damage (e.g., mucositis), and overall microbial exposure (i.e., colonization, environment, and prior infection). Since the 1990s, different risk-stratification strategies have been evaluated in order to identify those patients who may benefit from intensive prophylactic and diagnostic measures. However, despite having similar risk profiles, only a subset of AML patients will develop an IFI. One of the most exciting recent advances in the understanding of the epidemiology of IFIs is the recognition of the complexity of the host and the identification of new host-related risk factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all newly diagnosed AML who accept to take part to the registry and sign an informed consent
排除标准
- •relapsing/refractory AML
- •patients who do not sign informed consent
结局指标
主要结局
Incidence of Invasive fungal infections
时间窗: 30th day after the end of first line chemotherapy
To identify possible fungal infections sources for the period preceding the diagnosis of leukemia, in particular those related to normal activities of daily life (e.g. occupation, location and type of residence, consume of tobacco, alcohol or illicit drugs and others).
次要结局
未报告次要终点
