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

Pfizer

Status: Terminated

Conditions: Candidemia; Invasive Candidiasis

Treatments: Other: Does not apply

Study type: Observational

Funder types: Industry

Identifiers

NCT01213823

A8851024

Details and patient eligibility

About

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.

Enrollment: 536 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

536 participants in 2 patient groups

Cases

Description:

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)

Treatment:

Other: Does not apply

Other: Does not apply

Controls

Description:

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)

Treatment:

Other: Does not apply

Other: Does not apply