| 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 |
