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临床试验/NCT01684189
NCT01684189Unknown不适用

A Non-interventional Prospective Registry to Monitor the Events of Febrile Neutropenia and Invasive Fungal Infections and the Diagnostic and Therapeutic Management in Patients With Malignant Hematologic Diseases After Chemotherapy

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1

研究概览

简要总结

Objectives:

  1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy
  2. To explore the percentage/distribution of infectious origins of febrile neutropenia
  3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia
  4. To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes
  5. To have a clear view of therapeutic actions in the management of hematological patients with febrile neutropenia and suspected fungal-related febrile episodes

详细描述

Objectives:

  1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile episodes in patients receiving chemotherapy
  2. To explore the percentage/distribution of infectious origins of febrile neutropenia
  3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia
  4. To explore clinical outcomes of different infectious origins/pathogens in febrile neutropenia episodes
  5. To have a clear view of therapeutic actions in the management of hematological patients with febrile neutropenia and suspected fungal-related febrile episodes

Study Design:

  • This is a single institute, prospective, non-interventional registry for monitoring events of febrile neutropenia in hematological patients
  • Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry

Study Procedures: Data collection will include patients' basic information, underlying disease, baseline blood chemistry and blood cell counts, antifungal prophylaxis, C/T regimens, neutrophils and other blood cells, fever diagnosis and infectious sites work-up, clinical response, microbiology (including bacteria and fungus culture), renal and liver function, clinical diagnosis, work-up and intensive procedures and results, antifungal and antibacterial agents (including dosage, duration, and route), other drugs used (including antivirals, antineoplastics, corticosteroids, immunomodulators), clinical significant changes

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with new diagnosed hematological diseases (acute and chronic myeloid and lymphoid leukemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma, myelodysplastic syndromes)
  • Patients who are receiving chemotherapy and have ongoing febrile episodes

排除标准

  • 未提供

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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