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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:
ClinicalTrials.gov Identifier:
NCT01686607
First Posted: September 18, 2012
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
World Health Information Science Consultants, LLC
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
September 13, 2012
September 18, 2012
September 4, 2017
October 1, 2012
January 2020   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT01686607 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Patients treated with parenteral antifungals in tertiary referral centers across the United States.
Systemic Fungal Infections
  • Drug: Parenteral micafungin application
    Oral
  • Drug: Other parenteral antifungal drugs
    Oral
    Other Names:
    • caspofungin
    • anidulafungin
    • fluconazole
    • itraconazole
    • voriconazole
    • amphotericin B (various formulations)
    • 'other antifungals' include the following drugs:
  • 1) parenteral micafungin users
    patients who had been treated with parenteral micafungin
    Intervention: Drug: Parenteral micafungin application
  • 2) other parenteral antifungal users
    patients who had been treated with a parenteral antifungal agent (not micafungin)
    Intervention: Drug: Other parenteral antifungal drugs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40110
January 2020
January 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01686607
9463-CL-1401
No
Not Provided
Not Provided
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
Astellas Pharma Europe B.V.
World Health Information Science Consultants, LLC
Principal Investigator: Lead Investigator WHISCON, LLC
Astellas Pharma Inc
September 2017