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) ]

Severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified as: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [ULN] and direct bilirubin >2 times ULN and absence of alkaline phosphatase elevation); 3) ALT levels greater than or equal to (≥) 10 times ULN; 4) ALT levels >3 times ULN and less than (<) 10 times ULN; or 5) classified by clinician. Disease Related Group (DRG) severity of illness coding was reported for severe hepatic injury cases and matched controls.


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