Evaluation of Caspofungin or Micafungin as Empiric Antifungal Therapy in Adult Patients With Persistent Febrile Neutropenia: A Retrospective, Observational, Sequential Cohort Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN)
研究概览
简要总结
Invasive fungal infections are an important cause of morbidity and mortality in patients with neutropenia who are receiving chemotherapy for cancer. Early diagnosis of these infections is difficult and fever may be the only sign. A delay in treatment while a diagnosis is pursued may lead to increased morbidity and mortality. There are now several echinocandins available with similar in vitro spectrum of activity. Caspofungin is the only echinocandin Food and Drug Administration (FDA) approved for empiric antifungal therapy in febrile neutropenia. Although all echinocandin antifungal agents have similar spectrum of activity, there are limited data on the use of micafungin in patients with persistent fever and neutropenia (FN). In November 2006 the Pharmacy and Therapeutics Committee at Brigham & Women's Hospital / Dana Farber Cancer Institute (BWH/DFCI) switched from caspofungin to micafungin as our formulary echinocandin. Given the limited clinical data on the use of micafungin as empiric antifungal therapy in patients with FN, we sought to evaluate the safety and effectiveness of micafungin, compared with caspofungin, for this indication using a sequential cohort analysis of patients treated before and after the formulary change at Brigham and Women's Hospital.
详细描述
Objectives
This retrospective cohort analysis of converting from caspofungin to micafungin as empiric antifungal therapy for cancer patients who are persistently febrile and neutropenic after receiving broad spectrum antibiotics at Brigham & Women's Hospital / Dana Farber Cancer Institute (BWH/DFCI) is designed to evaluate the following objectives:
- Safety of micafungin in this patient population
- Effective dose of 100 mg daily of micafungin compared to 70mg x1, then 50 mg daily of caspofungin
- Economic impact of converting or formulary echinocandin from micafungin to caspofungin
Study Design
- Retrospective cohort analysis - limited to medical records
- Data to be collected include the following:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an Absolute Neutrophil Count (ANC) < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
- •All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an Absolute Neutrophil Count (ANC) < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
排除标准
- •Patients receiving an echinocandin antifungal agent (micafungin or caspofungin) for an indication other then empiric therapy in febrile neutropenia
- •Patients receiving therapy for an active or on-going invasive fungal infection
- •Patients who received both caspofungin and micafungin during the same admission
- •Patients with an ANC > 500 at when either micafungin or caspofungin was started
- •Patients who received another antifungal agent for persistent febrile neutropenia, e.g., voriconazole, amphotericin B liposome, posaconazole, etc... Before they received an echinocandin (caspofungin or micafungin) will be excluded
结局指标
主要结局
Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN)
时间窗: 11/1/2005 - 10/31/2007
Overall favorable response was defined as achievement of successful treatment of baseline fungal infections, survival to hospital discharge, absence of breakthrough Ivasive fungal disese (IFD), and lack of advserse events (AE) attributable to treatment that led to discontinuation of echinocandin therapy.
Successful Treatment of Any Baseline Invasive Fungal Disease (IFD)
时间窗: 11/1/2005 - 10/31/2007
Possible or proven baseline invasive fungal disease were defined as were diagnosed within the 2 days of initiating echinocandin therapy for persistent febrile neutropenia
Absence of Any Breakthrough Invasive Fungal Disease (IFD)
时间窗: 11/1/2005 - 10/31/2007
a breakthrough invasive fungal disesase was defined as any fungal infection that was diagnosed \> 3 days on or during therapy or within 7 days after completion of therapy with an echinocandin
Mortality at Hospital Discharge
时间窗: 11/1/2005 - 10/31/2007
We assessed all patients in the study cohort who dischaged from the hospital alive
Lack of an Adverse Drug Event (ADE) Attributable to Echinocandin (EC) Therapy That Led to Discontinuation of Therapy
时间窗: 11/1/2005 - 10/31/2007
Defined as any advsere event directly attributable to echinocandin treatment that led to discontinuation of therapy or switch to alternative therapy
次要结局
- Duration of Neutropenia(11/1/2005 - 10/31/2007)
- Duration of Echinocadin Therapy for Persistent Febrile Neutropenia (FN)(11/1/2005 - 10/31/2007)
- Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy(11/1/2005 - 10/31/2007)
- Duration of Hospitization(11/1/2005 - 10/31/2007)
- Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation(11/1/2005 - 10/31/2007)