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

Study Overview
=================
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.

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

Conditions
-----------------
Invasive Candidiasis, Candidemia

Intervention / Treatment
-----------------
* Other: Does not apply
* Other: Does not apply


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>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) | Other: Does not apply<br>* This is a non-interventional study, therefore the intervention type / name do not apply<br>|
| Controls<br>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) | Other: Does not apply<br>* This is a non-interventional study, therefore the intervention type / name do not apply<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Any Severe Hepatic Injury Cases and Matched Controls | 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. | 01 June 2006 to 30 June 2008 (up to 25 Months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
invasive candidiasis, candidemia, severe hepatic injury, echinocandins, anidulafungin, caspofungin, micafungin