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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01686607

Acronym

MYCOS

Enrollment

40110

Registered

2012-09-18

Start date

2012-10-01

Completion date

2018-04-30

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Fungal Infections

Keywords

Hepatic toxicity, Renal toxicity, Micafungin, Hepatocellular carcinoma, Antifungals (parenteral)

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.

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.

Interventions

DRUGParenteral micafungin application

Parenteral

DRUGOther parenteral antifungal drugs

Parenteral

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026