Name (Synonyms) | Correlation | |
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drug2626 | Vancomycin Wiki | 1.00 |
drug937 | Fidaxomicin Wiki | 1.00 |
Name (Synonyms) | Correlation | |
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D003141 | Communicable Diseases NIH | 0.09 |
D007239 | Infection NIH | 0.06 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection.
Description: The Primary outcome will be sustained clinical response as measured at study day 59 for all treatment regimens. Sustained clinical response is a composite outcome that includes symptom resolution during treatment without any of the following (as assessed on day 59): Diarrhea recurrence Other non-fatal clinical events including severe abdominal pain, toxic megacolon (where diarrhea ceases but is not a beneficial outcome), and colectomy Death
Measure: Determine symptom resolution during treatment without any of the following: diarrhea recurrence; other non-fatal clinical events including severe abdominal pain, toxic megacolon, and colectomy; and death. Time: Day 59 for all treatment regimens.Description: CDI Composite Outcome Measure (CDI-COM) is sustained clinical response without recurrent CDI (defined as diarrhea plus confirmation of toxigenic C. difficile or its toxins in stool) as measured at study day 59 for all three treatment regimens. Sustained response will be defined using the same composite endpoint criteria as were used in the D-COM outcome but without recurrent CDI on or before day 59.
Measure: CDI Composite outcome measure Time: Day 59 for all treatment regimens.