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

Last updated: March 2, 2016
Sponsor: Pfizer
Overall Status: Terminated

Phase

N/A

Condition

Yeast Infections

Gynecological Infections

Systemic Candidiasis

Treatment

N/A

Clinical Study ID

NCT01213823
A8851024
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 536
Study Start date:
September 01, 2008
Estimated Completion Date:
May 31, 2011