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Trial record 17 of 809 for:    Clotrimazole AND Fungal Infections

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

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.
 
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. )

Tracking Information
First Submitted Date September 13, 2012
First Posted Date September 18, 2012
Last Update Posted Date June 4, 2019
Actual Study Start Date October 1, 2012
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 13, 2012)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
Official Title A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated with parenteral antifungals in tertiary referral centers across the United States.
Condition Systemic Fungal Infections
Intervention
  • Drug: Parenteral micafungin application
    Parenteral
  • Drug: Other parenteral antifungal drugs
    Parenteral
    Other Names:
    • caspofungin
    • anidulafungin
    • fluconazole
    • itraconazole
    • voriconazole
    • amphotericin B (various formulations)
    • 'other antifungals' include the following drugs:
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 28, 2017)
40110
Original Estimated Enrollment
 (submitted: September 13, 2012)
35000
Actual Study Completion Date April 30, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01686607
Other Study ID Numbers 9463-CL-1401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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."
Responsible Party Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
Study Sponsor Astellas Pharma Europe B.V.
Collaborators World Health Information Science Consultants, LLC
Investigators
Principal Investigator: Lead Investigator WHISCON, LLC
PRS Account Astellas Pharma Inc
Verification Date May 2019