Evaluation of Caspofungin or Micafungin as Empiric Antifungal Therapy in Adult Patients With Persistent Febrile Neutropenia: A Retrospective, Observational, Sequential Cohort Analysis
18 Years
N/A
Both
Febrile Neutropenia
Trial Information
Evaluation of Caspofungin or Micafungin as Empiric Antifungal Therapy in Adult Patients With Persistent Febrile Neutropenia: A Retrospective, Observational, Sequential Cohort Analysis
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
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN)
Outcome Description:
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.
Outcome Time Frame:
11/1/2005 - 10/31/2007
Safety Issue:
No
Principal Investigator
David W Kubiak, PharmD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Brigham and Women's Hospital
Authority:
United States: Institutional Review Board
Study ID:
2008-P-000605/1; BWH
NCT ID:
NCT00723073
Start Date:
January 2008
Completion Date:
May 2008
Related Keywords:
- Febrile Neutropenia
- micafungin, caspofungin, febrile neutropenia
- Fever
- Neutropenia
Name | Location |
|---|---|
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
