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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-01

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Systemic Fungal Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1) parenteral micafungin users

patients who had been treated with parenteral micafungin

Parenteral micafungin application

Intervention Type DRUG

Parenteral

2) other parenteral antifungal users

patients who had been treated with a parenteral antifungal agent (not micafungin)

Other parenteral antifungal drugs

Intervention Type DRUG

Parenteral

Interventions

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Parenteral micafungin application

Parenteral

Intervention Type DRUG

Other parenteral antifungal drugs

Parenteral

Intervention Type DRUG

Other Intervention Names

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caspofungin anidulafungin fluconazole itraconazole voriconazole amphotericin B (various formulations) 'other antifungals' include the following drugs:

Eligibility Criteria

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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