Status:
TERMINATED
Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
Lead Sponsor:
Pfizer
Conditions:
Invasive Candidiasis
Candidemia
Eligibility:
All Genders
18-99 years
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 w...
Eligibility Criteria
Inclusion
- 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
- \< 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
536 Patients enrolled
Trial Details
Trial ID
NCT01213823
Start Date
September 1 2008
End Date
May 1 2011
Last Update
March 30 2016
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