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临床试验/NCT00945555
NCT00945555已完成不适用

Multi-Center, Non-Interventional, Observational Study To Evaluate The Antibacterial Therapeutical Options In Febrile Neutropenia Patients

Pfizer1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
264
试验地点
1
主要终点
Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical

研究概览

简要总结

The purpose of this study was to define and classify antibacterial agents used in Turkey for patients with 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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are 18 years old and above.
  • Patients who have undergone allogeneic/autologous or peripheral stem cell transplantation following induction or consolidation treatment due to acute hematological malignancy.
  • Patients who have a neutrophil count below 500 cells per cubic millimeter (cells/mm^3) or below 1000 cells/mm^3 with an expectancy to rapidly decrease below 500 cells/mm^
  • Patients with a body temperature more than or equal to (≥)38.3 degrees Celsius (101 degrees Fahrenheit) on single oral measurement or detected ≥38.0 degrees Celsius for at least an hour and thus started on antibacterial treatment will be included in the trial.

排除标准

  • Patients who are pregnant or considering pregnancy.

研究组 & 干预措施

All participants

Participants with febrile neutropenia who received antibacterial treatment per investigator's judgment

干预措施: Antibacterial agent for the treatment of febrile neutropenia (Drug)

结局指标

主要结局

Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical

时间窗: Baseline

Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted

时间窗: Baseline

次要结局

  • Mean Neutrophil Count(Baseline, Day 4, Day 7 on Average (till the End of Treatment))
  • Percentage of Participants in Whom New Infection Was Determined on Day 4(Day 4)
  • Percentage Survivors(Day 7 on Average (till the End of Treatment))
  • Percentage of Participants Who Had a Treatment Modification(Day 4, Day 7 on Average (till the End of Treatment))
  • Mean Body Temperature(Baseline, Day 4, Day 7 on Average (till the End of Treatment))
  • Percentage of Participants in Whom New Infection Was Determined at End of Treatment(Day 7 on Average (till the End of Treatment))

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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