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