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

Last updated on October 4, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Invasive Candidiasis, Candidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

-

- 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.

NCT01213823
Pfizer
Terminated
Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins

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Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
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.
  • Invasive Candidiasis
  • Candidemia
Other: Does not apply
This is a non-interventional study, therefore the intervention type / name do not apply
  • 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)
    Intervention: Other: Does 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)
    Intervention: Other: Does not apply
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
536
May 2011
May 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01213823
A8851024
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2016

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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