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Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Systemic Fungal Infections

Intervention: Parenteral micafungin application (Drug); Other parenteral antifungal drugs (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Astellas Pharma Europe B.V.

Official(s) and/or principal investigator(s):
Lead Investigator, Principal Investigator, Affiliation: WHISCON, LLC

Summary

This multicenter observational cohort study proposes to establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal agents from 2005 through 2012 with follow-up until 2017.

Clinical Details

Official title: A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome:

Treatment-emergent hepatic injury or dysfunction

Treatment-emergent renal failure or dysfunction

Rehospitalization for the parenteral treatment of fungal infections

Death from hepatocellular carcinoma (HCC)

Detailed description: All eligible patients treated with a parenteral antifungal agent at any time during the years 2005-2012 in each of the participating hospitals, will be included in the study.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- hospitalized and treated with parenteral antifungal medication

- first time treatment of the patient with parenteral antifungal in the medical center

was anytime from 2005 through 2012 Exclusion Criteria:

- prior diagnosis of hepatocellular carcinoma

- had received parenteral antifungal therapy during the 6 months prior to index

hospitalization

Locations and Contacts

Johns Hopkins University, Baltimore, Maryland 21218, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

University of Michigan Hospital and Health System, Ann Arbor, Michigan 48109, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

University of Pennsylvania Office of Research Services, Philadephia, Pennsylvania 19104-6205, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213-2582, United States

Additional Information

Starting date: October 2012
Last updated: June 15, 2015

Page last updated: August 23, 2015

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