- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01213823
Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
March 2, 2016 updated by: Pfizer
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
536
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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)
|
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)
|
This is a non-interventional study, therefore the intervention type / name do not apply
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Any Severe Hepatic Injury Cases and Matched Controls
Time Frame: 01 June 2006 to 30 June 2008 (up to 25 Months)
|
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.
|
01 June 2006 to 30 June 2008 (up to 25 Months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
September 30, 2010
First Submitted That Met QC Criteria
September 30, 2010
First Posted (Estimate)
October 4, 2010
Study Record Updates
Last Update Posted (Estimate)
March 30, 2016
Last Update Submitted That Met QC Criteria
March 2, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A8851024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Candidemia
-
Taipei Medical University WanFang HospitalCompletedNon-albicans CandidemiaTaiwan
-
Taipei Medical University WanFang HospitalUnknownCandidemia Prognostic Factor and Mycobiological Analysis.Taiwan
-
Fujian Shengdi Pharmaceutical Co., Ltd.Not yet recruitingPatients With Candidemia and/or Invasive Candidiasis
-
Centre Hospitalier Universitaire DijonUnknown
-
Karolinska University HospitalCompletedThe Value of Procalcitonin in Patients With Suspected CandidemiaSweden
-
Radboud University Medical CenterHorizon 2020 - European CommissionRecruitingCandidemiaNetherlands, United States, Switzerland, Germany, Romania, Greece
-
AM-PharmaWithdrawn
-
Assistance Publique - Hôpitaux de ParisUnknownInfection, FungalFrance
-
Universidade Federal do Rio de JaneiroCompleted
Clinical Trials on Does not apply
-
Jörg SchefoldCompletedRenal Failure | Acute Kidney Injury | Dialysis | Aortic Surgery | BiomarkerSwitzerland
-
Jörg SchefoldCompleted
-
University Hospital MuensterMukoviszidose eV Bonn GermanyCompletedCystic FibrosisAustria, Germany
-
Corporacion Parc TauliHospital Mutua de Terrassa; Consorci Sanitari de TerrassaCompleted
-
Virginia Polytechnic Institute and State UniversityRecruitingInflammatory ResponseUnited States
-
Charite University, Berlin, GermanyCompletedAcute Renal FailureGermany
-
University Hospital, AngersNot yet recruiting
-
Ethiopian Public Health InstituteNetherlands: Ministry of Health, Welfare and SportsUnknownClinical | Epidemiology | Nutritional-status | Immunologic DefectEthiopia
-
Chang Gung Memorial HospitalMinistry of Science and Technology, TaiwanCompleted