Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: May 2011

Interventions

  • Other: Does not apply
    • This is a non-interventional study, therefore the intervention type / name do not apply
  • Other: Does not apply
    • This is a non-interventional study, therefore the intervention type / name do not apply

Arms, Groups and Cohorts

  • Cases
    • Potential cases were defined as patients with a diagnosis of severe hepatic injury identified in the acute-care inpatient cohort using ICD-9 codes associated with the case definition of severe liver injury. Case status was validated by a Consultant Gastroenterologist blinded to study drug exposure via medical record review using an apriori algorithm. Only validated cases were included in the analysis (N=69)
  • Controls
    • Controls were defined as patients without a diagnosis of severe hepatic injury (i.e. with no ICD-9 codes associated with the case definition of severe liver injury) selected at random from the same acute-care inpatient cohort as cases (N=467)

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Acute-care inpatients; – Aged 18 years or older; – At least one dose of echinocandin therapy during the hospitalization; – Primary or secondary ICD-9 discharge diagnosis of invasive candidiasis / candidemia. Exclusion Criteria:

  • < 18 years of age; – No recorded echinocandin therapy during hospitalization; – Acetaminophen hepatotoxicity; – Pre-existing autoimmune hepatitis; – Autoimmune/metabolic liver disease; – Primary biliary cirrhosis; – Primary sclerosing cholangitis and orthotopic liver transplantation.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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