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

Candidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01213823
• Other study ID #: A8851024
• Status: Terminated
• Phase: Phase 4
• First received: September 30, 2010
• Last updated: January 4, 2016
• Start date: September 2008
• Est. completion date: May 2011

Study information

• Verified date: January 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 536
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Candidemia
• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiasis

Intervention

Other:
• Does not apply
This is a non-interventional study, therefore the intervention type / name do not apply
• Does not apply
This is a non-interventional study, therefore the intervention type / name do not apply

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Any Severe Hepatic Injury Cases and Matched Controls	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.	01 June 2006 to 30 June 2008	Yes

External Links

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