Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy: a Multicenter Validation of Clinical Decision Rule
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,900
- 试验地点
- 1
- 主要终点
- Fungal culture
研究概览
简要总结
Evaluate the reproducibility and validate a posteriori a new rule of clinical decision on a multi-center population of children with a post-chemotherapy febrile neutropenia
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child aged 1 to 18 years
- •Child with hematology or cancer
- •Child with a febrile neutropenia post-chemotherapy
- •Child with social security
- •No opposition from the child and/or parents, in case of absence, the holder of the parental authority present, can consent, alone, to the participation of the unemancipated minor.
排除标准
- •Febrile neutropenia at diagnosis of tumor disease
- •Child with palliative care
- •Child having had a hematopoietic stem cell allo-graft in the preceding year
- •Febrile neutropenia immediately post auto-transplant
- •Antibiotherapy prior to admission
- •Initial care in a non-investigative center.
结局指标
主要结局
Fungal culture
时间窗: On average between 5 days and 1 month
Presence or not of fungal infection is referred to a proven, probable, or possible fungal infection as defined by the IFICG ot the EORTC
microbiological culture
时间窗: On average between 5 days and 1 month
Presence or not of focal infection at high risk of dissemination was defined as any local infection with or without microbiological documentation into a normally sterile site, with significant risk of loco-regional or systemic spread
Blood culture
时间窗: On average between 5 days and 1 month
Presence or not of bacteriemia
Positive bacterial culture from a normally sterile site
时间窗: on average between 5 days and 1 month
Presence or not of bacterial infection
次要结局
未报告次要终点