Trial Outcomes & Findings for Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins (NCT NCT01213823)

Last Updated: 2016-03-30

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

536 participants

Primary outcome timeframe

01 June 2006 to 30 June 2008 (up to 25 Months)

Results posted on

2016-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	69	467
Overall Study COMPLETED	69	467
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cases n=69 Participants 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 n=467 Participants 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 n=536 Participants Total of all reporting groups
Age, Customized 18-24 years	1 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants
Age, Customized 25-34 years	1 Participants n=5 Participants	26 Participants n=7 Participants	27 Participants n=5 Participants
Age, Customized 35-44 years	5 Participants n=5 Participants	42 Participants n=7 Participants	47 Participants n=5 Participants
Age, Customized 45-54 years	15 Participants n=5 Participants	73 Participants n=7 Participants	88 Participants n=5 Participants
Age, Customized 55-64 years	16 Participants n=5 Participants	76 Participants n=7 Participants	92 Participants n=5 Participants
Age, Customized 65-74 years	18 Participants n=5 Participants	111 Participants n=7 Participants	129 Participants n=5 Participants
Age, Customized Greater than or equal to (>=) 75 years	13 Participants n=5 Participants	127 Participants n=7 Participants	140 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	245 Participants n=7 Participants	274 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	222 Participants n=7 Participants	262 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Cases n=69 Participants 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 n=467 Participants 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.
Number of Any Severe Hepatic Injury Cases and Matched Controls DRG Severity Coding 1	0 Participants	1 Participants
Number of Any Severe Hepatic Injury Cases and Matched Controls DRG Severity Coding 2	0 Participants	10 Participants
Number of Any Severe Hepatic Injury Cases and Matched Controls DRG Severity Coding 3	1 Participants	66 Participants
Number of Any Severe Hepatic Injury Cases and Matched Controls DRG Severity Coding 4	68 Participants	389 Participants

Adverse Events

Cases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER