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

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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Fungal Infections
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 40110

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Site US4
  • Massachusetts
    • Boston, Massachusetts, United States, 02119
      • Site US2
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Site US6
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Site US3
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Site US5
    • Pittsburgh, Pennsylvania, United States, 15213
      • Site US1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with parenteral antifungals in tertiary referral centers across the United States.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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: itraconazole; fluconazole; caspofungin; voriconazole; anidulafungin; amphotericin B (various formulations); 'other antifungals' include the following drugs:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Death from hepatocellular carcinoma (HCC)	On a long-term basis up to 13 years from 2005-2017.	Up to 13 years after treatment

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe B.V.
• Collaborators: World Health Information Science Consultants, LLC
• Investigators: Principal Investigator: Lead Investigator, WHISCON, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: September 13, 2012
• First Submitted That Met QC Criteria: September 13, 2012
• First Posted (Estimate): September 18, 2012

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: May 31, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Micafungin; Hepatocellular carcinoma; Renal toxicity; Hepatic toxicity; Antifungals (parenteral)
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Amebicides; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Micafungin; Caspofungin; Antifungal Agents; Clotrimazole; Miconazole; Itraconazole; Anidulafungin; Fluconazole; Amphotericin B; Voriconazole
• Other Study ID Numbers: 9463-CL-1401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."