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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: October 7, 2014
Last verified: October 2014

September 13, 2012
October 7, 2014
October 2012
April 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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01686607 on ClinicalTrials.gov Archive Site
Not Provided
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
  • Drug: Other parenteral antifungal drugs
    Other Names:
    • 'other antifungals' include the following drugs:
    • caspofungin, anidulafungin, fluconazole, itraconazole, voriconazole, amphotericin B (various formulations)
  • 1) parenteral micafungin users
    Intervention: Drug: Parenteral micafungin application
  • 2) other parenteral antifungal users
    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
35000
November 2020
April 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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01686607
9463-CL-1401
No
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
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP