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

Systemic Fungal Infections Clinical Trial

— MYCOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686607
• Other study ID #: 9463-CL-1401
• Status: Completed
• Start date: October 1, 2012
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40110
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Mycoses
• Systemic Fungal Infections

Intervention

Drug:
• Parenteral micafungin application
Parenteral
• Other parenteral antifungal drugs
Parenteral

Locations

Country	Name	City	State
United States	Site US6	Ann Arbor	Michigan
United States	Site US4	Baltimore	Maryland
United States	Site US2	Boston	Massachusetts
United States	Site US3	Durham	North Carolina
United States	Site US5	Philadelphia	Pennsylvania
United States	Site US1	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.	World Health Information Science Consultants, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Death from hepatocellular carcinoma (HCC)	On a long-term basis up to 13 years from 2005-2017.	Up to 13 years after treatment