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

Astellas

Status: Completed

Conditions: Systemic Fungal Infections

Treatments: Drug: Parenteral micafungin application; Drug: Other parenteral antifungal drugs

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01686607

9463-CL-1401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40,110 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

40,110 participants in 2 patient groups

1) parenteral micafungin users

Description:

patients who had been treated with parenteral micafungin

Treatment:

Drug: Parenteral micafungin application

2) other parenteral antifungal users

Description:

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

Treatment:

Drug: Other parenteral antifungal drugs