Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
NCT01213823
ABOUT THIS STUDY
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- 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.
- < 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.
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Descriptive Information | ||||
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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 |
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Intervention | Other: Does not apply
This is a non-interventional study, therefore the intervention type / name do not apply | |||
Study Groups/Cohorts |
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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 | 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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Pfizer | |||
Verification Date | March 2016 |