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

Astellas Pharma Europe B.V.40,110 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

40,110

Conditions

Systemic Fungal Infections

Interventions

Parenteral micafungin applicationDRUG

Parenteral

Other parenteral antifungal drugsDRUG

Parenteral

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 (6)

Site US4

Baltimore, Maryland, United States

Site US2

Boston, Massachusetts, United States

Site US6

Ann Arbor, Michigan, United States

Site US3

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Treatment-emergent hepatic injury or dysfunction

Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.

Time frame: Up to 30 days after termination of the index treatment

Treatment-emergent renal failure or dysfunction

Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.

Time frame: Up to 30 days after termination of the index treatment

Rehospitalization for the parenteral treatment of fungal infections

Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.

Time frame: Up to 30 days after termination of the index treatment

Death from hepatocellular carcinoma (HCC)

On a long-term basis up to 13 years from 2005-2017.

Time frame: Up to 13 years after treatment

Data from ClinicalTrials.gov

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