The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Incidence of invasive aspergillosis in acute myeloid leukemia
研究概览
简要总结
Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose invasive aspergillosis (IA). These infections are leading to an important morbidity and mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during neutropenia induced by induction chemotherapy. Their application is not uniform.
详细描述
Invasive aspergillosis are frequent infections in hematological malignancy in particular during neutropenia induced by chemotherapy. Their incidence ranged between 5 to 25% according to the literature. Mortality may reach 30%. Our study described IA incidence in AML patients treated by intensive chemotherapy depending on antifungal prophylaxis by posaconazole. From 2009 to 2011, any patients received antifungal prophylaxis. From 2012 to 2015, patients received posaconazole during induction and salvage chemotherapy. During the all study period, efficacy of posaconazole is evaluated according to construction/demolition periods in hospital. All patients are hospitalized in High Efficiency Particulate Air (HEPA) filtration system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •> 18 years
- •acute myeloid leukemia
- •intensive chemotherapy (induction, consolidation, salvage, bone marrow transplantation)
排除标准
- •< 18 years
- •pregnancy
- •no intensive chemotherapy (palliative treatment, azacytidine...)
研究组 & 干预措施
Patients without antifungal prophylaxis
Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2009 to 2011, any patient received antifungal (anti-aspergillosis) prophylaxis.
干预措施: Patients without antifungal prophylaxis (Other)
Patients with antifungal prophylaxis
Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2012 to 2015, all patients received antifungal (anti-aspergillosis) prophylaxis by posaconazole.
干预措施: Patients without antifungal prophylaxis (Other)
Patients with antifungal prophylaxis
Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2012 to 2015, all patients received antifungal (anti-aspergillosis) prophylaxis by posaconazole.
干预措施: Patients with antifungal prophylaxis (Drug)
结局指标
主要结局
Incidence of invasive aspergillosis in acute myeloid leukemia
时间窗: 1 year
Evaluation of annual incidence of invasive aspergillosis in acute myeloid leukemia treated by intensive chemotherapy between 2009 and 2015
次要结局
- Efficiency of antifungal prophylaxis by posaconazole(1 year)
- Impact of antifungal prophylaxis by posaconazole about construction/demolition periods(1 year)