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临床试验/NCT06797648
NCT06797648尚未招募不适用

Epidemiology of Infection in AML, A European Haematology Association Survey

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Incidence of bacterial/fungal/viral infections in AML patients

研究概览

简要总结

In recent years, multiple factors have strongly impacted the epidemiology of infections in patients with acute myeloid leukemia. On the one hand, the availability of new effective antileukemic drugs (i.e. venetoclax, FLT-3 inhibitors, CPX-351) have expanded the pharmacological armamentarium. On the other hand, first, many of them inhere drug-drug interactions with azoles and fluoroquinolones, facing clinicians with the choice of whether to administer antimicrobial prophylaxis or not. Secondly, there is an increase in infections due to multi-resistant agents from both the bacterial and fungal field. Third, the onset of a viral pandemic that had high relevance in these patients in terms of morbidity and mortality.

The aim of this survey is to collect information on the largest possible sample of patients with AML during induction/consolidation/relapsed-refractory treatment, regarding bacterial, viral, fungal infections. We will evaluate the incidence of the various types of infection in relation to the type of treatment that patients will undergo, in order to identify what should be the best antimicrobial prophylactic approach in each subset of patients.

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

  • Ability to sign the consent form
  • Age ≥18 years
  • New diagnosis of AML (only cases diagnosed after 01/03/2025), APL are included
  • Patients not elegible to any kind of chemotherapy but only best supportive care (BSC)
  • AML patients treated with induction treatment, consolidation treatment, or relapsed/refractory (for these latter patients the first diagnosis must not be prior to March 01, 2025)
  • All kind of infectious diseases, including parasites.
  • Clincally or microbiologically diagnosed infections, including FUO

排除标准

  • Hematological diseases, other than AML
  • Patients with an AML diagnosis prior to March 2025 but who relapsed during the period under examination
  • Patients relapsed after allo or auto-HSCT (Inclusion of post-transplant patients would create an evaluation bias due to the immunological alterations that the transplant procedure causes)

结局指标

主要结局

Incidence of bacterial/fungal/viral infections in AML patients

时间窗: 18 months

To evaluate the incidence of bacterial/fungal/viral infections in AML patients undergoing induction, consolidation or salvage chemotherapy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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