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

This study has been terminated.
(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.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01213823
First received: September 30, 2010
Last updated: March 2, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Invasive Candidiasis
Candidemia
Other: Does not apply
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Any Severe Hepatic Injury Cases and Matched Controls [ Time Frame: 01 June 2006 to 30 June 2008 (up to 25 Months) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 536
Study Start Date: September 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cases
Potential cases were defined as patients with a diagnosis of severe hepatic injury identified in the acute-care inpatient cohort using ICD-9 codes associated with the case definition of severe liver injury. Case status was validated by a Consultant Gastroenterologist blinded to study drug exposure via medical record review using an apriori algorithm. Only validated cases were included in the analysis (N=69)
Other: Does not apply
This is a non-interventional study, therefore the intervention type / name do not apply
Controls
Controls were defined as patients without a diagnosis of severe hepatic injury (i.e. with no ICD-9 codes associated with the case definition of severe liver injury) selected at random from the same acute-care inpatient cohort as cases (N=467)
Other: Does not apply
This is a non-interventional study, therefore the intervention type / name do not apply

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Acute-care inpatients aged 18 years or older, with at least one dose of echinocandin antifungal therapy during the hospitalization and a primary or secondary ICD-9 discharge diagnosis of invasive candidiasis / candidemia identified in the Premier's PerspectiveTM Comparative Database (PCD) from 01 June 2006 to 30 June 2008.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213823

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01213823     History of Changes
Other Study ID Numbers: A8851024 
Study First Received: September 30, 2010
Results First Received: April 9, 2012
Last Updated: March 2, 2016
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
invasive candidiasis
candidemia
severe hepatic injury
echinocandins
anidulafungin
caspofungin
micafungin

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Candidemia
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Echinocandins
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 25, 2016