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

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ClinicalTrials.gov Identifier: NCT01686607
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
World Health Information Science Consultants, LLC
Information provided by (Responsible Party):
Astellas Pharma Inc ( 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.

Condition or disease Intervention/treatment
Systemic Fungal Infections 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.

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Study Type : Observational
Actual Enrollment : 40110 participants
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
Actual Study Start Date : October 1, 2012
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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:
  • caspofungin
  • anidulafungin
  • fluconazole
  • itraconazole
  • voriconazole
  • amphotericin B (various formulations)
  • 'other antifungals' include the following drugs:




Primary Outcome Measures :
  1. Treatment-emergent hepatic injury or dysfunction [ Time Frame: 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.

  2. Treatment-emergent renal failure or dysfunction [ Time Frame: 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.

  3. Rehospitalization for the parenteral treatment of fungal infections [ Time Frame: 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.

  4. Death from hepatocellular carcinoma (HCC) [ Time Frame: Up to 13 years after treatment ]
    On a long-term basis up to 13 years from 2005-2017.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686607


Locations
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United States, Maryland
Site US4
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Site US2
Boston, Massachusetts, United States, 02119
United States, Michigan
Site US6
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
Site US3
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Site US5
Philadelphia, Pennsylvania, United States, 19104
Site US1
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Astellas Pharma Europe B.V.
World Health Information Science Consultants, LLC
Investigators
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Principal Investigator: Lead Investigator WHISCON, LLC

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Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT01686607     History of Changes
Other Study ID Numbers: 9463-CL-1401
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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."

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

Additional relevant MeSH terms:
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Mycoses
Itraconazole
Voriconazole
Amphotericin B
Antifungal Agents
Miconazole
Micafungin
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