Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 536
- 主要终点
- Number of Any Severe Hepatic Injury Cases and Matched Controls
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •< 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.
结局指标
主要结局
Number of Any Severe Hepatic Injury Cases and Matched Controls
时间窗: 01 June 2006 to 30 June 2008 (up to 25 Months)
Severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified as: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase \[ALT\] levels greater than \[\>\]3 times the upper limit of normal \[ULN\] and direct bilirubin \>2 times ULN and absence of alkaline phosphatase elevation); 3) ALT levels greater than or equal to (≥) 10 times ULN; 4) ALT levels \>3 times ULN and less than (\<) 10 times ULN; or 5) classified by clinician. Disease Related Group (DRG) severity of illness coding was reported for severe hepatic injury cases and matched controls.
次要结局
未报告次要终点