Retrospective Observation of Empirical Antifungal Therapy With Itraconazole
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 主要终点
- Success rate of itraconazole treatment when used for more than 7 days
研究概览
简要总结
The purpose of this study is to investigate the overall success rate of itraconazole intravenous treatment for a period of more than 7 days.
详细描述
This is a retrospective study ie, a study that looks backward in time, usually using medical records and interviews with patients who are already known to have a disease, in patients with itraconazole intravenous prescription as an empirical (based on practical experience) antifungal agent. This study collects baseline information about underlying disease, sign of fungal infection, neutropenia (a decrease in white blood cells), neutropenic fever duration and the reason for discontinuation. Neutropenia is defined as a neutrophil (white blood cell) count of ≤500 cells/mm3 or a count of ≤1000 cells/mm3 with a predicted decrease to ≤500 cells/mm3. Fever is defined as a body temperature ≥38.3 Celsius degrees at least once a day with no definite external factor or a body temperature of ≥38 Celsius degrees continued for at least 1 hour.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with neutropenic fever who receive therapy for inhibiting or preventing development of neoplasms (abnormal growth of tissue) or stem cell transplantation (stem cell is a cell whose daughter cells may differentiate into other cell types) for hematologic malignancies (cancers that affect blood, bone marrow and lymph nodes)
- •Patients who receive itraconazole intravenous (IV) treatment for more than 7 days
排除标准
- •Childbearing women who are pregnant or likely to be pregnant during the study period and men who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception
- •Fever due to documented fungal infection
- •Hepatic dysfunction
- •Kidney abnormalities
- •Patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion
研究组 & 干预措施
Itraconazole
干预措施: Itraconazole (Drug)
结局指标
主要结局
Success rate of itraconazole treatment when used for more than 7 days
时间窗: From 7 days to approximately 2 weeks
Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.
次要结局
- Success rate of itraconazole treatment until neutropenia is resolved(Approximately 2 weeks)
- Drop out rate due to the lack of efficacy of itraconazole treatment(Approximately 2 weeks)