Myelodysplasic Syndromes and Risk Factors for Infection : A Case / Control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Occurrence of infectious episode
研究概览
简要总结
Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone marrow failure and by a disorder of the medullary production which is a pre-leukemic state which can evolve into acute myeloid leukemia.
The risk of leukemic transformation is estimated by the score IPSS (International Prognostic Score System). We distinguish the MDS of low risk (IPSS<1) and those of high risk of leukemic transformation (IPSS=1,5).
Besides the risk of leukemic transformation, MDS much be complicated of infections which could be life-threatening.
The risk of developing first infection after the diagnosis of MDS of high risk is probably influenced by anamnestic (disease duration, comorbidities), clinical (veinous central catheter, previous hospitalization), biological (neutropenia, lymphopenia, serum ferritin) and therapeutics (demethylating agent, lenalidomide, erythropoietin, G-CSF, transfusions, anti-infectious preventive treatment) factors. Their identification will allow for improved targeting of the population which is is likely to benefit from anti-infective prophylaxis Primary objective is to identify risk factors associated with first acute episode of infection in patients with MDS, by comparing index cases and matched control cases who did not develop infection episode since diagnosis.
Secondary objectives are to explore nature and severity of infectious episodes, number of recurrences during 1 year of follow up and survival at 6 and 12 months
详细描述
- 160 couples (Case / Control)
- Pairing according to age (+/- 5 years), sex and medical consultation date (+/-15 days)
- Follow up at M3, M6, M9 and M12
- Study duration : 24 months
- Inclusion duration : 12 months
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Age > 18 years old
- •MDS with IPSS >1.5
- •With a first infectious episode since the diagnosis of SMD of high risk (Case)
- •Unhurt of any infection and being able to be mated in the case index (Control)
- •Consulting or hospitalized in one of the services involved in the study during the period of inclusion
排除标准
- 未提供
结局指标
主要结局
Occurrence of infectious episode
时间窗: 12 months follow-up
次要结局
- severity of infectious episode(12 months follow-up)
- Overall Survival (all-cause mortality)(12months follow-up)