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

Completed

• Conditions: Systemic Fungal Infections
• Interventions: Drug: Parenteral micafungin application; Drug: Other parenteral antifungal drugs

• Registration Number: NCT01686607
• Lead Sponsor: Astellas Pharma Europe B.V.

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.

Study Timeline

• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-13
• Study First Posted: 2012-09-18
• Study Start: 2012-10-01
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2019-05
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1) parenteral micafungin users	Parenteral micafungin application	patients who had been treated with parenteral micafungin
2) other parenteral antifungal users	Other parenteral antifungal drugs	patients who had been treated with a parenteral antifungal agent (not micafungin)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Site US4; 🇺🇸 Baltimore, Maryland, United States

Site US2; 🇺🇸 Boston, Massachusetts, United States

Site US1; 🇺🇸 Pittsburgh, Pennsylvania, United States

Site US6; 🇺🇸 Ann Arbor, Michigan, United States

Site US5; 🇺🇸 Philadelphia, Pennsylvania, United States

Site US3; 🇺🇸 Durham, North Carolina, United States