跳至主要内容
临床试验/NCT00934115
NCT00934115Unknown不适用

Epidemiology of Infections in Pediatric Cancer Patients: A Prospective Multicenter Study in Israel

Rabin Medical Center0 个研究点目标入组 200 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200

研究概览

简要总结

Infections are common causes of morbidity and mortality in pediatric cancer patients. Today, there are limited data on the incidence, distribution of specific infections, causative agents and risk factors for severe infections in this population. Moreover, little data exist on the epidemiology of infections among pediatric patients with solid tumors.

The objectives of the present study are to define the incidence, categories of infections by organ systems, etiologic agents and risk factors for infections in different pediatric malignancies. The results of this study will help the investigators to better understand the epidemiology of infections in the different types of pediatric malignancies, enable the investigators to identify high risk patients, and design a better approach to empiric treatment of these patients.

A prospective, multi-center study, conducted in 5 pediatric hematology-oncology units across Israel (Rambam Medical Center, Haemek Medical Center, Schneider Children's Medical Center, Hadassah Medical Center, Soroka Medical Center). All children aged 0-18 years of age, newly diagnosed with cancer and admitted to day care or inpatient departments with fever of >38.0 C will be included in the study. Demographic, clinical and microbiological figures will be collected in each center by a research assistant supervised by the infectious disease specialist. Data will be collected according to a pre-defined Patient Data Form and entered into an electronic data base that will be analyzed accordingly. In each event of febrile episode during chemotherapy, the following data will be collected by a research assistant using a patient data form and computerized software:

  • Demographic data: age, gender, ethnicity.
  • Clinical data: Underlying disease, immunizations, prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy, duration of fever, duration and severity of neutropenia, diagnosis of present event.
  • Imaging data
  • Microbiological data
  • Outcome

The statistical analysis will be performed by an epidemiologist and statistician using the SPSS 12.0 software.

研究设计

研究类型
Observational
观察模型
Cohort

入排标准

年龄范围
— 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric cancer patients admitted to hospital with fever

排除标准

  • 未提供

研究者

申办方类型
Other

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