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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
World Health Information Science Consultants, LLC
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01686607
First received: September 13, 2012
Last updated: March 3, 2016
Last verified: March 2016
  Purpose
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 Intervention
Systemic Fungal Infections
Drug: Parenteral micafungin application
Drug: Other parenteral antifungal drugs

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Treatment-emergent hepatic injury or dysfunction [ Time Frame: Up to 30 days after termination of the index treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 30 days after termination of the index treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 30 days after termination of the index treatment ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Up to 13 years after treatment ] [ Designated as safety issue: Yes ]
    On a long-term basis up to 13 years from 2005-2017.


Estimated Enrollment: 35000
Study Start Date: October 2012
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1) parenteral micafungin users Drug: Parenteral micafungin application
2) other parenteral antifungal users Drug: Other parenteral antifungal drugs
Other Names:
  • 'other antifungals' include the following drugs:
  • caspofungin, anidulafungin, fluconazole, itraconazole, voriconazole, amphotericin B (various formulations)

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with parenteral antifungals in tertiary referral centers across the United States.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686607

Locations
United States, Maryland
Site US4 Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Site US2 Brigham and Women's Hospital
Boston, Massachusetts, United States, 02119
United States, Michigan
Site US6 University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
Site US3 Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Site US5 University of Pennsylvania-Abramson CCC-Dept. of Hem Onc
Philadephia, Pennsylvania, United States, 19104-6205
Site US1 University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Astellas Pharma Europe B.V.
World Health Information Science Consultants, LLC
Investigators
Principal Investigator: Lead Investigator WHISCON, LLC
  More Information

Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT01686607     History of Changes
Other Study ID Numbers: 9463-CL-1401 
Study First Received: September 13, 2012
Last Updated: March 3, 2016
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Antifungals (parenteral)
Micafungin
Hepatocellular carcinoma
Hepatic toxicity
Renal toxicity

Additional relevant MeSH terms:
Mycoses
Micafungin
Echinocandins
Antifungal Agents
Itraconazole
Voriconazole
Amphotericin B
Miconazole
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Cytochrome P-450 CYP2C9 Inhibitors

ClinicalTrials.gov processed this record on December 02, 2016