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

Sponsor

Astellas Pharma Europe B.V. (Industry)

Overall Status

Completed

CT.gov ID

NCT01686607

Collaborator

World Health Information Science Consultants, LLC (Other)

40,110

Enrollment

Locations

66.9

Actual Duration (Months)

6685

Patients Per Site

99.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Fungal Infections	Drug: Parenteral micafungin application Drug: Other parenteral antifungal drugs

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.

Study Design

Study Type:

Observational

Actual Enrollment :

40110 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Apr 30, 2018

Actual Study Completion Date :

Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
1) parenteral micafungin users patients who had been treated with parenteral micafungin	Drug: Parenteral micafungin application Parenteral
2) other parenteral antifungal users patients who had been treated with a parenteral antifungal agent (not micafungin)	Drug: Other parenteral antifungal drugs Parenteral Other Names: caspofungin anidulafungin fluconazole itraconazole voriconazole amphotericin B (various formulations) 'other antifungals' include the following drugs:

Arm

Intervention/Treatment

1) parenteral micafungin users

patients who had been treated with parenteral micafungin

Drug: Parenteral micafungin application

Parenteral

2) other parenteral antifungal users

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

Drug: Other parenteral antifungal drugs

Parenteral

Other Names:

caspofungin

anidulafungin

fluconazole

itraconazole

voriconazole

amphotericin B (various formulations)

'other antifungals' include the following drugs:

Outcome Measures

Primary Outcome Measures

Treatment-emergent hepatic injury or dysfunction [Up to 30 days after termination of the index treatment]
Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Treatment-emergent renal failure or dysfunction [Up to 30 days after termination of the index treatment]
Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Rehospitalization for the parenteral treatment of fungal infections [Up to 30 days after termination of the index treatment]
Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Death from hepatocellular carcinoma (HCC) [Up to 13 years after treatment]
On a long-term basis up to 13 years from 2005-2017.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site US4	Baltimore	Maryland	United States	21205
2	Site US2	Boston	Massachusetts	United States	02119
3	Site US6	Ann Arbor	Michigan	United States	48109
4	Site US3	Durham	North Carolina	United States	27710
5	Site US5	Philadelphia	Pennsylvania	United States	19104
6	Site US1	Pittsburgh	Pennsylvania	United States	15213