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Voriconazole as Prophylaxis for Liver Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00177788
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 16, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Pittsburgh

Brief Summary:
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 or disease
Fungemia Mycoses

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.

Study Type : Observational
Actual Enrollment : 800 participants
Time Perspective: Retrospective
Official Title: Voriconazole as Prophylaxis for Liver Transplant Recipients
Study Start Date : September 2005
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

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U.S. FDA Resources





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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.

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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

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177788     History of Changes
Other Study ID Numbers: IRB # 0508150
First Posted: September 15, 2005    Key Record Dates
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
Invasive Fungal Infections
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