Candidemia, Invasive Candidiasis
Conditions
Keywords
invasive candidiasis, candidemia, severe hepatic injury, echinocandins, anidulafungin, caspofungin, micafungin
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.
Interventions
OTHERDoes not apply
This is a non-interventional study, therefore the intervention type / name do not apply
Sponsors
Pfizer
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Any Severe Hepatic Injury Cases and Matched Controls | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cases 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. | 69 |
| Controls 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. | 467 |
| Total | 536 |
Baseline characteristics
| Characteristic | Cases | Controls | Total |
|---|---|---|---|
| Age, Customized 18-24 years | 1 Participants | 12 Participants | 13 Participants |
| Age, Customized 25-34 years | 1 Participants | 26 Participants | 27 Participants |
| Age, Customized 35-44 years | 5 Participants | 42 Participants | 47 Participants |
| Age, Customized 45-54 years | 15 Participants | 73 Participants | 88 Participants |
| Age, Customized 55-64 years | 16 Participants | 76 Participants | 92 Participants |
| Age, Customized 65-74 years | 18 Participants | 111 Participants | 129 Participants |
| Age, Customized Greater than or equal to (>=) 75 years | 13 Participants | 127 Participants | 140 Participants |
| Sex: Female, Male Female | 29 Participants | 245 Participants | 274 Participants |
| Sex: Female, Male Male | 40 Participants | 222 Participants | 262 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 01 June 2006 to 30 June 2008 (up to 25 Months)
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cases | Number of Any Severe Hepatic Injury Cases and Matched Controls | DRG Severity Coding 1 | 0 Participants |
| Cases | Number of Any Severe Hepatic Injury Cases and Matched Controls | DRG Severity Coding 2 | 0 Participants |
| Cases | Number of Any Severe Hepatic Injury Cases and Matched Controls | DRG Severity Coding 3 | 1 Participants |
| Cases | Number of Any Severe Hepatic Injury Cases and Matched Controls | DRG Severity Coding 4 | 68 Participants |
| Controls | Number of Any Severe Hepatic Injury Cases and Matched Controls | DRG Severity Coding 4 | 389 Participants |
| Controls | Number of Any Severe Hepatic Injury Cases and Matched Controls | DRG Severity Coding 1 | 1 Participants |
| Controls | Number of Any Severe Hepatic Injury Cases and Matched Controls | DRG Severity Coding 3 | 66 Participants |
| Controls | Number of Any Severe Hepatic Injury Cases and Matched Controls | DRG Severity Coding 2 | 10 Participants |