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NCT Number: NCT00723073

Caspofungin or Micafungin as Empiric Antifungal Therapy for Persistent Fever and Neutropenia

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.

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Key information

Conditions

Febrile Neutropenia Agranulocytosis Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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:
  • Demographic information: including: gender, age, race
  • Past medical history and admitting diagnoses
  • Laboratory results: Liver function tests (LFTs), Including alanine aminotransferase (ALT), aspartate aminotransferase (AST), Total bilirubin, as well as serum fungal assays: Serum Galactomannan assay, 1.3-BD Glucan assay
  • Concomitant medications and duration of therapy for all systemic: antibiotics and antifungals
  • All invasive breakthrough fungal infection details, including speciation and outcomes during echinocandin therapy
  • Dosing, duration, and adverse events associated with echinocandin therapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN)

    Time frame: 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.

  2. Successful Treatment of Any Baseline Invasive Fungal Disease (IFD)

    Time frame: 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

  3. Mortality at Hospital Discharge

    Time frame: 11/1/2005 - 10/31/2007

    We assessed all patients in the study cohort who dischaged from the hospital alive

  4. Absence of Any Breakthrough Invasive Fungal Disease (IFD)

    Time frame: 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

  5. Lack of an Adverse Drug Event (ADE) Attributable to Echinocandin (EC) Therapy That Led to Discontinuation of Therapy

    Time frame: 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

Secondary outcomes

  1. Duration of Echinocadin Therapy for Persistent Febrile Neutropenia (FN)

    Time frame: 11/1/2005 - 10/31/2007

    median duration of therapy with an echinocandin (caspofungin or micafungin) for persistent febrile neutropenia (FN)

  2. Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy

    Time frame: 11/1/2005 - 10/31/2007

    aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 5x the upper limit of normal (ULN) or total bilirubin > 3x the upper limit of normal (ULN)

  3. Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation

    Time frame: 11/1/2005 - 10/31/2007

    The description of the adverse event that resulted in discontinuation of echinocandin (EC) therapy

  4. Duration of Hospitization

    Time frame: 11/1/2005 - 10/31/2007

    Median number of days patients were hospitalized during the study period

  5. Duration of Neutropenia

    Time frame: 11/1/2005 - 10/31/2007

    Median number of days patients were neutropenic during the study period

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Official study title

Evaluation of Caspofungin or Micafungin as Empiric Antifungal Therapy in Adult Patients With Persistent Febrile Neutropenia: A Retrospective, Observational, Sequential Cohort Analysis

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 28, 2008
Registry last updated
Aug 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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