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

Febrile Neutropenia Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Neutropenia

• NCT number: NCT00723073
• Study type: Observational
• Source: Brigham and Women's Hospital
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Completion date: May 2008