Voriconazole as Prophylaxis for Liver Transplant Recipients

This study is ongoing, but not recruiting participants.

First Received: September 13, 2005 Last Updated: December 16, 2008 History of Changes

Sponsors and Collaborators:	University of Pittsburgh Pfizer
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177788

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

MedlinePlus related topics: Fungal Infections Liver Transplantation

Drug Information available for: Voriconazole

U.S. FDA Resources

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

Further study details as provided by University of Pittsburgh:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	800
Study Start Date:	September 2005
Estimated Study Completion Date:	November 2012

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:	UPMC ( David Paterson, MD )
Study ID Numbers:	IRB # 0508150
Study First Received:	September 13, 2005
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00177788 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

liver transplant
voriconazole prophylaxis
liver transplantation
voriconazole

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Mycoses
Sepsis
Clotrimazole
Miconazole

Antifungal Agents
Voriconazole
Tioconazole
Fungemia
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Anti-Infective Agents
Mycoses
Sepsis
Pathologic Processes
Therapeutic Uses

Antifungal Agents
Voriconazole
Fungemia
Infection
Pharmacologic Actions
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009