跳至主要内容
临床试验/CTRI/2021/09/036930
CTRI/2021/09/036930尚未招募不适用

Febrile Neutropenia in the Oncological setting: A prospective observational study

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年1月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
1
主要终点
To evaluate the outcomes of febrile neutropenia viz resolution of fever, progression to hemodynamic instability, ICU transfer and death.

研究概览

简要总结

Febrile neutropenia is the most common and serious adverse event on intensive chemotherapy. With the advent of multi-drug resistant bacterial sepsis the mortality due to infections is on the rise. We would like to prospectively study the spectrum of febrile neutropenia at our hospital across all disease management groups. The study will also help us come up with predictive models for high risk febrile neutropenia with increased risk of mortality. This understanding will help us develop specific interventions and shape antibiotic policies.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Subjects with all age group will be included for the study.
  • Receiving chemotherapy for newly diagnosed or relapsed malignancy.
  • Febrile neutropenia defined as fever (temperature >100.4 F on two occasions within a 12 hour period or 101°F once) during neutropenia (absolute neutrophil count < 500 x 109 cells/L or absolute neutrophil count <1000 x 109 cells/L and falling).

排除标准

  • Non-chemotherapy related febrile neutropenia.
  • Fever due to underlying malignancy c.
  • Non neutropenic fever.

结局指标

主要结局

To evaluate the outcomes of febrile neutropenia viz resolution of fever, progression to hemodynamic instability, ICU transfer and death.

时间窗: From the time of enrollment till resolution of the febrile neutropenia episode or death of the patient, whichever earlier.

次要结局

  • 1. To evaluate the incidence of MDR organism (Details in Appendix-2)(2. To evaluate baseline prognostic factors for outcome.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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