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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Invasive Candidiasis; Candidemia

Intervention: Does not apply (Other); Does not apply (Other)

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

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

Study design: Observational Model: Case Control, Time Perspective: Retrospective

Primary outcome: Severe hepatic injury: acute liver failure; Hy's Law; ALT ≥ 10 x ULN; ALT between 3 and 10 x ULN

Detailed description: The study was terminated on May 5, 2011, due to methodological issues. The decision to terminate the study was not based on any safety or efficacy concerns.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: September 2008
Last updated: May 26, 2011

Page last updated: August 23, 2015

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