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

Last updated on December 5, 2019

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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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Descriptive Information
Brief TitleRisk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
Official TitleRisk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
Brief SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationAcute-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
  • Invasive Candidiasis
  • Candidemia
InterventionOther: Does not apply
This is a non-interventional study, therefore the intervention type / name do not apply
Study Groups/Cohorts
  • 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
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 StatusTerminated
Actual Enrollment
 (submitted: September 30, 2010)
536
Original Actual EnrollmentSame as current
Actual Study Completion DateMay 2011
Actual Primary Completion DateMay 2011   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy VolunteersYes
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01213823
Other Study ID NumbersA8851024
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2016

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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