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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.

Deliverables (2)
Mini-Sentinel Modular Program Report: Clostridium difficile Infection Following Use of Vancomycin, Fidaxomicin, or Metronidzaole, Report 1 Mini-Sentinel Modular Program Report: Clostridium difficile Infection Following Use of Vancomycin, Fidaxomicin, or Metronidzaole, Report 2
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)