Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 8
- 主要终点
- positivity of the viral PCR in the presence of clinical signs during periods of positivity of the PCR in the presence of clinical signs
研究概览
简要总结
Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.
详细描述
Bacterial and fungal infection treatment is well defined with guidelines. Few data are available for viral infections and concern essentially allogeneic stem cell transplantation. These infections are associated with a high mortality and morbidity rate. Data concerning AML are essentially retrospective, pediatric and with a little number of patients. Respiratory viral infections incidence is not known. These infections may be responsible for a higher mortality rate. Different risk factors are found: age superior to 65 years, lymphopenia, co-infections. Treatment is subject to a controversy: surveillance or starting an antiviral therapy. This study aims at understanding viral infections epidemiology during long term aplasia and optimizing their management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old with an AML diagnostic and treated with induction and consolidation chemotherapy. Patients enrolled in another protocol may be included.
- •Patients with relapsed leukemia who are treated with a salvage intensive therapy stay in the study
- •Patients who have signed a consent policyholder
排除标准
- •patients under 18 years old
- •patients treated with another treatment than induction and consolidation chemotherapy
- •pregnant women
- •patients HIV, HBV or HBC positive
- •patients with a positive PCR at J1
- •patients treated with an antiviral treatment or an immunosuppressive treatment for another pathology
- •patients under guardianship
- •Primitive immunity Deficit
研究组 & 干预措施
patient with Acute Myeloïd Leukemia
干预措施: Multiplex respiratory viral PCR (Other)
结局指标
主要结局
positivity of the viral PCR in the presence of clinical signs during periods of positivity of the PCR in the presence of clinical signs
时间窗: at day 15
Positivity of the viral PCR in the presence of clinical signs during periods of Aplasia following chemotherapy induction and consolidation defining viral infection.
次要结局
- seasonal viral infection incidence measure(18 months after inclusion)
- risk factor of viral infections research(18 months after inclusion)
- viral infections related morbidity and mortality estimation(18 months after inclusion)
- bacterial and fungal co-infection estimation(18 months after inclusion)
- description of antiviral therapeutic used for treating patients(18 months after inclusion)