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

This study has been terminated.
(See Detailed Description fot Termination Statement)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01213823
First received: September 30, 2010
Last updated: May 26, 2011
Last verified: May 2011
  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:
  • Severe hepatic injury: acute liver failure; Hy's Law; ALT ≥ 10 x ULN; ALT between 3 and 10 x ULN [ Time Frame: May 2011 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01213823     History of Changes
Other Study ID Numbers: A8851024
Study First Received: September 30, 2010
Last Updated: May 26, 2011
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
Candidemia
Wounds and Injuries
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014