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
Observational
Observational Model: Cohort, Time Perspective: Retrospective
Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN)
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.
11/1/2005 - 10/31/2007
No
David W Kubiak, PharmD
Principal Investigator
Brigham and Women's Hospital
United States: Institutional Review Board
2008-P-000605/1; BWH
NCT00723073
January 2008
May 2008
Name | Location |
---|---|
Brigham and Women's Hospital | Boston, Massachusetts 02115 |