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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01213823
Other study ID # A8851024
Secondary ID
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


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
See also
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