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Sponsors and Collaborators: |
Brigham and Women's Hospital Astellas Pharma US, Inc. |
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Information provided by: | Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00723073 |
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 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. In November 2006 the Pharmacy and Therapeutics Committee at BWH/DFCI switched from caspofungin to micafungin as our formulary echinocandin. We plan to evaluate the safety, efficacy, and economic impact of switching from caspofungin to micafungin at our institution for empiric antifungal therapy in febrile neutropenia.
Condition |
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Febrile Neutropenia |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | Evaluating the Conversion of Caspofungin (CAS) to Micafungin (MIC) as Empiric Antifungal Therapy in Patients With Persistent Fever and Neutropenia |
Enrollment: | 334 |
Study Start Date: | January 2008 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Caspofungin arm
All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an ANC < 500, for persistent febrile neutropenia from 11/1/2005 - 10/31/2006, as there first antifungal agent.
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Micafungin arm
All patients admitted to BWH/DFCI who received at least 2 doses of micafungin with an ANC < 500 for persistent febrile neutropenia from 11/1/2006 - 10/31/2007 as there first antifungal agent
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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 and Women's Hospital is designed to evaluate the following objectives:
Study Design
Data to be collected include the following:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Cancer patients who are persistently febrile and neutropenic after receiving broad spectrum antibiotics and receive empiric antifungal therapy with either caspofungin or micafungin
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | David W Kubiak, PharmD | Brigham and Women's Hospital |
Responsible Party: | Brigham and Women's Hospital ( David W, Kubiak, PharmD, BCPS / Infectious Disease Clinical Specialist ) |
Study ID Numbers: | 2008-P-000605/1; BWH |
Study First Received: | July 24, 2008 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00723073 |
Health Authority: | United States: Federal Government |
micafungin, caspofungin, febrile neutropenia |
Fever Neutropenia Clotrimazole Hematologic Diseases Miconazole Caspofungin |
Tioconazole Agranulocytosis Leukocyte Disorders Leukopenia Granulocytopenia Micafungin |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Pharmacologic Actions |