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Clostridium difficile Infection Following Use of Vancomycin, Fidaxomicin, or Metronidzaole

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    fidaxomicin
    metronidazole
    vancomycin
    Health Outcome(s)
    clostridium difficile
    Description

    These reports estimate the rate of hospital re-admission with Clostridium difficile (C. difficile) infection (identified using International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 008.45) following treatment with oral vancomycin, fidaxomicin, or metronidazole. Data from January 1, 2000 to December 31, 2012 from 18 Data Partners contributing to the Mini-Sentinel Distributed Database (MSDD) were utilized for the two reports that encompass this request. This request was distributed to Data Partners on August 27, 2013. Report 1 contains results from the first run, which has a query period of May 1, 2011 to December 31, 2012. Report 2 has a query period of January 1, 2000 to December 31, 2012.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2000 - December 31, 2012
    Analysis Type
    Mini-Sentinel
    Population / Cohort
    All individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)