Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Retrospective
Conditions Invasive Candidiasis
Candidemia
Intervention Other: Does not apply
Enrollment 536
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cases Controls
Hide Arm/Group Description Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 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 [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician. Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
Period Title: Overall Study
Started 69 467
Completed 69 467
Not Completed 0 0
Arm/Group Title Cases Controls Total
Hide Arm/Group Description Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 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 [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician. Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury. Total of all reporting groups
Overall Number of Baseline Participants 69 467 536
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 467 participants 536 participants
18-24 years 1 12 13
25-34 years 1 26 27
35-44 years 5 42 47
45-54 years 15 73 88
55-64 years 16 76 92
65-74 years 18 111 129
Greater than or equal to (>=) 75 years 13 127 140
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 467 participants 536 participants
Female
29
  42.0%
245
  52.5%
274
  51.1%
Male
40
  58.0%
222
  47.5%
262
  48.9%
1.Primary Outcome
Title Number of Any Severe Hepatic Injury Cases and Matched Controls
Hide Description 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.
Time Frame 01 June 2006 to 30 June 2008 (up to 25 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Acute-care participants, with at least 1 dose of echinocandin antifungal therapy and a primary or secondary International Classification of Diseases 9 (ICD-9).
Arm/Group Title Cases Controls
Hide Arm/Group Description:
Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 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 [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
Overall Number of Participants Analyzed 69 467
Measure Type: Number
Unit of Measure: Participants
DRG Severity Coding 1 0 1
DRG Severity Coding 2 0 10
DRG Severity Coding 3 1 66
DRG Severity Coding 4 68 389
Time Frame [Not Specified]
Adverse Event Reporting Description In this retrospective observational study, adverse events were not collected as a part of this study.
 
Arm/Group Title Cases Controls
Hide Arm/Group Description Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 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 [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician. Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
All-Cause Mortality
Cases Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cases Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cases Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Study results were invalidated due to lack of temporality, a critical methodological element of the study that was never established for the majority of the cases of severe hepatic injury.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01213823     History of Changes
Other Study ID Numbers: A8851024
First Submitted: September 30, 2010
First Posted: October 4, 2010
Results First Submitted: April 9, 2012
Results First Posted: February 4, 2016
Last Update Posted: March 30, 2016