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Voriconazole as Prophylaxis for Liver Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177788
First received: September 13, 2005
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177788     History of Changes
Other Study ID Numbers: IRB # 0508150
Study First Received: September 13, 2005
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

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
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013