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

Terminated

• Conditions: Invasive Candidiasis; Candidemia
• Interventions: Other: Does not apply

• Registration Number: NCT01213823
• Lead Sponsor: Pfizer

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 Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-09-30
• Study First Posted: 2010-10-04
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2012-04-09
• Results First Submitted QC: 2016-01-04
• Results First Posted: 2016-02-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 536

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Does not apply	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	Does not apply	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)

Primary Outcome Measures

Name	Time	Method
Number of Any Severe Hepatic Injury Cases and Matched Controls	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.