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临床试验/NCT07060612
NCT07060612进行中(未招募)不适用

Incidencia y Factores de Riesgo Para el Desarrollo de infección fúngica Invasiva en Pacientes Con diagnóstico de Leucemia mieloblástica Aguda

Instituto de Investigacion Sanitaria La Fe1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
300
试验地点
1
主要终点
Primary objectives

研究概览

简要总结

Patients diagnosed with acute myeloblastic leukemia (AML) who receive intensive chemotherapy treatment have a high incidence of invasive fungal infection (IFI). IFI is a significant cause of morbidity and mortality in this population. Its diagnosis is generally challenging, leading to delays in treatment initiation and a worse prognosis. Various strategies have been proposed to improve outcomes: prophylaxis, empirical treatment, and preemptive strategies, but the optimal approach remains unknown.

Several authors advocate for tailoring IFI control strategies based on local IFI incidence and the risk factors present in each epidemiological area. In AML patients treated at our center, a thorough understanding of IFI incidence, associated risk factors, and the strategies adopted for its control during different historical periods will allow us to optimize patient management in the future to improve outcomes.

To this end, the investigators propose conducting a retrospective epidemiological study that captures routine clinical practice in the management of IFI at our center from January 1, 2015, to December 31, 2024. This study will record data on diagnosis, patient characteristics, and the development of IFI, regardless of age or treatment received.

Secondarily, the investigators aim to determine the incidence and epidemiological characteristics of IFI in this population, identify and confirm risk factors, and retrospectively evaluate the diagnostic and control strategies adopted for IFI across different historical periods. The study design will be retrospective, documenting routine IFI management practices at our center. No diagnostic or therapeutic interventions will be performed. All patients diagnosed with AML from January 1, 2015, to December 31, 2024, will be included, regardless of AML subtype, disease progression, or treatment received. Data will be collected on key AML characteristics at diagnosis, treatment received and number of cycles, IFI diagnosis according to the 2008 EORTC/MSG criteria, and the management of this complication.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with AML regardless of the treatment received (first line and relapsed/refractory).
  • Patients older than 15 years (adult unit) No contraindications for antifungal therapy/prophylaxis.

排除标准

  • Patients with acute promyelocytic leukemia (APL). Patients with insufficient data (not evaluable).

结局指标

主要结局

Primary objectives

时间窗: 9 years

To evaluate the incidence and risk factors for the development of IFI/BIFD in patients diagnosed with AML, regardless of the treatment received (first-line and relapsed/refractory patients).

次要结局

未报告次要终点

研究者

发起方
Instituto de Investigacion Sanitaria La Fe
申办方类型
Other
责任方
Sponsor

研究点 (1)

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