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

NCT ID: NCT01213823

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 536 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-05-31

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.

Conditions

Invasive Candidiasis; Candidemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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)

Does not apply

Intervention Type: OTHER

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)

Does not apply

Intervention Type: OTHER

This is a non-interventional study, therefore the intervention type / name do not apply

Interventions

Does not apply

This is a non-interventional study, therefore the intervention type / name do not apply

Intervention Type: OTHER

Does not apply

This is a non-interventional study, therefore the intervention type / name do not apply

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8851024&StudyName=Risk%20Of%20Severe%20Hepatic%20Injury%20In%20Patients%20With%20Invasive%20Candidiasis%20Treated%20With%20Echinocandins

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Other Identifiers

A8851024

Identifier Type: -

Identifier Source: org_study_id