Risk Factors & Outcomes for Clinically Documented Infections in Pediatric Cancer Patients With Fever & Neutropenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Clinically documented infection e.g., pneumonia, gastroenteritis, meningitis, septicemia, etc.
研究概览
简要总结
The aim of the study is to identify clinical and laboratory parameters, present at the time of initial evaluation that could help predict which children with cancer, fever, and neutropenia will be at risk for developing clinically documented infections and/ or complications.
详细描述
Background:
It has long been recognized that not all neutropenic patients have the same risk of developing serious infections and/or complications.
Fever and infection represent the most important complications of myeloablative cytotoxic therapy that results in severe mucositis and prolonged neutropenia .
One of the most important concepts in the approach to infections in the febrile neutropenic patient is the recognition of risk. Risk can be defined in two ways. First, risk may be defined in terms of the probability for developing a febrile neutropenic infection; and second, it may be defined in terms of the likelihood for significantly poor outcomes due to that infection.
An understanding of the risks in the latter case may be used to define the approaches to management; for instance, in-patient versus out-patient treatment strategies and administration of intravenous versus oral formulations of antimicrobial therapy. These considerations have significant economic and quality of life ramifications.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose age less than 19 years.
- •Patients diagnosed with hematologic malignancies or solid tumors.
- •Patients admitted at the pediatric oncology department for at least 24-hour period after documentation of an episode of fever & neutropenia at the time of initial evaluation at the pediatric oncology clinic.
- •Patients who previously have been admitted at the pediatric oncology department, after documentation of an episode of fever & neutropenia.
排除标准
- •Patients whose age is more than 18 years.
- •Patients not fulfilling the criteria for diagnosis of fever and neutropenia.
结局指标
主要结局
Clinically documented infection e.g., pneumonia, gastroenteritis, meningitis, septicemia, etc.
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Recovery from fever neutropenia episode OR occurrence of clinically documented infection
次要结局
- Death as a complication for infections(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
研究者
Ahmed Mohammed Morsy, MD
Lecturer, Pediatric Oncology Department
Assiut University