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临床试验/NCT00026767
NCT00026767已完成不适用

Surveillance of Invasive Fungal Infections in Bone Marrow/Stem Cell and Solid Organ Transplantation Recipients and Other Immunocompromised Patients: A Prospective Study

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2001年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
217
试验地点
1

研究概览

简要总结

This study will collect data on the incidence (rate of occurrence) of fungal infections in recipients of bone marrow, stem cell or organ transplants. The data will provide information needed to develop strategies for prevention and early treatment of fungal infections in these patients.

Any patient receiving bone marrow transplantation, peripheral stem cell transplantation or solid organ transplantation is eligible for this study.

The survey will be conducted over a 3-year period at about 20 collaborating transplant centers. Through the annual accrual of more than 9,000 patients, it is estimated that at least 5 to 8 percent per year will have documented or suspected invasive fungal infections.

The study will be conducted in three phases as follows:

  • Phase 1 A 6-month "start-up" phase during which sites will initiate screening and begin collecting data on incident cases of invasive fungal infections.
  • Phase 2 A 2-year phase in which all sites will conduct surveillance and collect data and specimens in a standardized fashion.
  • Phase 3 A 6-month "wrap-up" phase during which active surveillance for invasive fungal infections will be conducted only among patients who were transplanted before the beginning of this phase.

Patient care will be provided through the patient s primary protocol and standard of care.

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详细描述

Background:

Invasive fungal infections have emerged as important causes of morbidity and mortality among recipients of bone marrow, stem cell, and solid organ transplantation (SOT), as well as patients receiving intensive chemotherapy for treatment of hematological malignancies, patients with aplastic anemia, and patients with inherited immunodeficiencies.

This study has been formerly conducted through a surveillance network of BMT/SCT and SOT centers through collaboration with the Centers for Disease Control for the surveillance of invasive fungal infections in recipients of bone marrow, stem cell transplantation, and solid organ transplantations.

The first three phases of this study will have been conducted over a six-year period at approximately 23 collaborating transplant centers and completed enrollment of multi-center cases of March 31, 2006.

The addition of a fourth phase allows the study of cases of invasive fungal infections to continue by extending the protocol for four years at the NIH Clinical Center.

研究设计

研究类型
Observational

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih

研究点 (1)

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