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

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ClinicalTrials.gov Identifier: NCT01213823
Recruitment Status : 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.)
First Posted : October 4, 2010
Results First Posted : February 4, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 30, 2010
First Posted Date October 4, 2010
Results First Submitted Date April 9, 2012
Results First Posted Date February 4, 2016
Last Update Posted Date March 30, 2016
Study Start Date September 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 2, 2016)
Number of Any Severe Hepatic Injury Cases and Matched Controls [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: September 30, 2010)
Severe hepatic injury: acute liver failure; Hy's Law; ALT ≥ 10 x ULN; ALT between 3 and 10 x ULN
Change History Complete list of historical versions of study NCT01213823 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
Official Title Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Invasive Candidiasis
  • Candidemia
Intervention Other: Does not apply
This is a non-interventional study, therefore the intervention type / name do not apply
Study Groups/Cohorts
  • 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)
    Intervention: Other: Does 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)
    Intervention: Other: Does not apply
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: September 30, 2010)
536
Original Actual Enrollment Same as current
Actual Study Completion Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01213823
Other Study ID Numbers A8851024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2016