Observational Prospective Multicenter Study to Evaluate the Infective Risk in Myelodysplastic Syndrome Patients: Antimicrobial Prophylaxis and Granulocyte Growth Factors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 25
- 主要终点
- Number of infectious events in myelodysplastic syndrome patients
研究概览
简要总结
The purpose of this study is to observe the number of new cases of infections per population in a given time period and their characteristics in a pathology (myelodysplastic syndrome, MDS)that involves ineffective production (or dysplasia) of a class of blood cells.
详细描述
The scarcity and the inadequacy of data make impossible the writing of evidence-based recommendations for prevention and management of infections in myelodysplastic syndrome.
The aim of this study is to evaluate the incidence and the spectrum of the infections of MDS patients. Will be also evaluated potential risk factors.
This study could help the definition of the optimal management of MDS patients in terms of prophylaxis of the infective complications and in terms of the correct administration of growth factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •All adult patients (>18 years) with newly diagnosed myelodysplastic syndrome or patients who have undergone a bone marrow reevaluation;
- •Signed written informed consent;
排除标准
- •Psychiatric patients;
- •Patients with life expectancy less than three months.
研究组 & 干预措施
Myelodysplastic syndrome patients
Patients affected by myelodysplastic syndrome enrolled in the observational study
干预措施: Antibiotic and antifungal drugs (Drug)
结局指标
主要结局
Number of infectious events in myelodysplastic syndrome patients
时间窗: at 1 year from study entry
Infectious events are fungal and antibiotic events
次要结局
- Number of patients that needed granulocyte growth factors(at 1 year from study entry)
- Number of MDS patients with a febrile event treated with antibiotic, antifungal and antiviral therapy(at 1 year from study entry)
- Level of neutropenia(at 1 year from study entry)
- Number of patients who don't develop bacterial infection(at 1 year from study entry)
- Length of the hospitalization(at 1 year from study entry)
- Weeks of MDS suspension treatment(at 1 year from study entry)
- Number of patients who recover from infection(at 1 year from study entry)
- Number of patient who don't develop viral infection(at 1 year from study entry)
- Number of patients without MDS progression(at 1 year from study entry)
- Level of iron overload(At one year from study entry.)
- Number of patients recovered from infection out of the total of patients with documented infection during the observational period(at 1 year from study entry)
- Number of patient who don't develop fungal infection(at 1 year from study entry)
- Number of patients that needed iron sequestrating therapy caused by iron overload(at 1 year from study entry)
- Number of patients responding to therapy according to the administered treatment(at 1 year from study entry)
- Need for hospitalization(at 1 year from study entry)
- Level of International Prognostic Scoring System (IPSS)-revised(At one year from study entry)
- Number of MDS patients alive(at 1 year from study entry)
- Level transfusion dependence(At one year from study entry)
- Level of MDS subtype(At one year from study entry)
- Level of risk of International Prognostic Scoring System (IPSS)(At one year from study entry)