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

Study Overview
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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.

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.

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

Conditions
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Systemic Fungal Infections

Intervention / Treatment
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* Drug: Parenteral micafungin application
* Drug: Other parenteral antifungal drugs


Participation Criteria
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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 Exclusion Criteria: prior diagnosis of hepatocellular carcinoma had received parenteral antifungal therapy during the 6 months prior to index hospitalization
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1) parenteral micafungin users<br>patients who had been treated with parenteral micafungin | Drug: Parenteral micafungin application<br>* Parenteral<br>|
| 2) other parenteral antifungal users<br>patients who had been treated with a parenteral antifungal agent (not micafungin) | Drug: Other parenteral antifungal drugs<br>* Parenteral<br>* Other names: 'other antifungals' include the following drugs:;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Up to 13 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic toxicity, Renal toxicity, Micafungin, Hepatocellular carcinoma, Antifungals (parenteral)