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临床试验/NCT06188182
NCT06188182尚未招募不适用

D-index as a Predictor of Complications of Febrile Neutropenia in Patients With Acute Myeloid Leukemia

Assiut University0 个研究点目标入组 60 人开始时间: 2024年6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
60
主要终点
The effect of D-index on the onset and severity of FN in AML patients.

研究概览

简要总结

  1. The effect of D-index on the onset and severity of FN in AML patients.
  2. Relationship between the c-D-index and duration of FN in AML patients.
  3. Correlation between D-index and MDR.
  4. Correlation between D-index and invasive fungal infection.
  5. Comparison of FN in different treatment protocols for AML using D-index.
  6. Prediction of pulmonary, fungal or blood stream infection.

详细描述

Acute myeloid leukemia (AML) is highly malignant neoplasm responsible for a large number of cancer-related deaths. It continuously shows 2 peaks in occurrence in early childhood and later adulthood. With an incidence of 3.7 per 100,000 persons per year.

Neutropenia, defined as the absolute neutrophil count (ANC) below 500 cells/ μL or ANC expected to drop below 500 cells/ μL in the next 48 h, represents a potentially fatal complication and is associated with a high risk of developing bacterial infections. Fever is defined as having a bodily temperature above 38.3 ˚C, measured orally, or two measurements above 38 ˚C that are taken at different time points, at least an hour apart.

Concomitance of severe neutropenia (≤ 500 cells/ μL) with high fever (≥ 38.3˚C) is called febrile neutropenia (FN) by the definition of the Infectious Diseases Society of America (IDSA).

Invasive fungal infection (IFI) and bacterial blood stream infection (BSI) consideded a major complications during AML treatment and associated with high morbidity and mortality. Immunosuppression caused by chemotherapy and prolonged hospitalizations expose AML patients to life threatening infections, which can be sustained by multi-drug resistant organisms (MDROs), accounting for one of the major causes of mortality.

A clinical parameter that evaluates the dynamics of neutropenia, combining intensity and duration, could be a good tool to identify patients at high risk for infection. This tool could be used to stratify patients, helping clinicians to select appropriate antibiotics and antifungal therapy in persistently febrile neutropenic patients. An index (called the D-index) that uses data from WBC counts and combines intensity and duration of neutropenia.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Patients (≥18 years) newly diagnosed as acute myeloid leukemia according to WHO 2016 diagnostic criteria.
  • Hematologic diagnosis of de novo AML.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0-
  • Standard induction chemotherapy (7+3 regimen) or consolidation regimens (HiDAC).

排除标准

  • AML on top of other hematological disorders. 2) Acute promyelocytic leukemia. 3) Patients who received palliative care or low-intensity treatment. 4) Poor PS (≥3) at the time of diagnosis.

结局指标

主要结局

The effect of D-index on the onset and severity of FN in AML patients.

时间窗: during the period of chemotherapy completion, an average of 1 year

Determine if the D-index can predict the onset, severity, duration and complications of febrile neutropenia

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esraa Nageh Adam

Assistant Lecture

Assiut University

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