Clinical Trial: Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational
Official Title: Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
Brief Summary: The purpose of this study is to estimate the relative risk of severe hepatic injury in hospitalized patients with invasive candidiasis and candidemia who received anidulafungin, compared to patients who received caspofungin and/or micafungin.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome: Number of Any Severe Hepatic Injury Cases and Matched Controls [ Time Frame: 01 June 2006 to 30 June 2008 (up to 25 Months) ]
Original Primary Outcome: Severe hepatic injury: acute liver failure; Hy's Law; ALT ≥ 10 x ULN; ALT between 3 and 10 x ULN
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Pfizer
Dates:
Date Received: September 30, 2010
Date Started: September 2008
Date Completion:
Last Updated: March 2, 2016
Last Verified: March 2016