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

Project Title Clostridium difficile Infection Following Use of Vancomycin, Fidaxomicin, or Metronidzaole
Date Posted
Tuesday, April 3, 2018
Project ID
msy4_mpr57_v1
Status
Complete
Deliverables
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.

Medical Product
fidaxomicin
metronidazole
vancomycin
Health Outcome
clostridium difficile
Population / Cohort
All individuals
Time Period
January 1, 2000 - December 31, 2012
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER