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Voriconazole as Prophylaxis for Liver Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00177788
First Posted: September 15, 2005
Last Update Posted: August 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Pittsburgh
  Purpose
The study aims to determine if voriconazole prevents invasive fungal infections in liver transplant recipients. Endpoints would be: occurrence of invasive fungal infection and fungal colonization. Two groups will be compared: patients who received voriconazole as prophylaxis and historical controls who did not receive this prophylaxis.

Condition
Fungemia Mycoses

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Voriconazole as Prophylaxis for Liver Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Enrollment: 800
Study Start Date: September 2005
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:
The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, voriconazole usage prophylactically, physical exam findings, laboratory and radiographical data, antimicrobial usage, microbiological data and resistance patterns, choice of antifungal drugs once organism identified, suspected source of infection, microbiological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, weight, ethnicity, and past medical history.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
liver transplant patients receiving voriconazole
Criteria

Inclusion Criteria:

  • Patients receiving a liver transplant at University of Pittsburgh Medical Center (UPMC) between January 1, 2001 and June 30, 2005.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177788


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Pfizer
Investigators
Principal Investigator: David Paterson, MD University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177788     History of Changes
Other Study ID Numbers: IRB # 0508150
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: August 16, 2012
Last Verified: August 2012

Keywords provided by University of Pittsburgh:
liver transplant
voriconazole prophylaxis
liver transplantation
voriconazole

Additional relevant MeSH terms:
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors


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