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...
Date First Received: September 13, 2005
Last Updated: December 16, 2008
Verified by: University of Pittsburgh, December 2008
Clinical Trial Phase: N/A | Start Date: September 2005
Overall Status: Active, not recruiting
Estimated Enrollment: 800
Brief Summary
Official Title: “Voriconazole as Prophylaxis for Liver Transplant Recipients”
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.
Study Type: Observational
Study Design: Other, Retrospective
Detailed Clinical Trial 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.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients receiving a liver transplant at University of Pittsburgh Medical Center (UPMC) between January 1, 2001 and June 30, 2005.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Pittsburgh
Overall Clinical Trial Officials and Contacts
David Paterson, MD Principal Investigator University of Pittsburgh
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00177788
Study ID Number: IRB # 0508150
ClinicalTrials.gov Identifier: NCT00177788
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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