跳至主要内容
临床试验/NCT01254318
NCT01254318已完成不适用

Temporal Realistic Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (TRAFIC)

Merck Sharp & Dohme LLC0 个研究点目标入组 130 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
主要终点
Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution

研究概览

简要总结

This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada. The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk participants. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • To be eligible for study inclusion, the participant must have:
  • A hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant

排除标准

  • The participant is not eligible for study inclusion if:
  • Their IFI is not related to hematological malignancies.

结局指标

主要结局

Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution

时间窗: 365 days

Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.

次要结局

  • Percentage of Participants With a Specific Fungal Pathogen at a Single Institution(365 days)
  • Percentage of Participants With Invasive Fungal Infections in Canada(365 days)

研究者

申办方类型
Industry
责任方
Sponsor

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