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NCT00177788 Clinical Trial

Voriconazole as Prophylaxis for Liver Transplant Recipients

Mycoses Clinical Trial

Official title:
Voriconazole as Prophylaxis for Liver Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00177788
Other study ID # IRB # 0508150
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated August 14, 2012
Start date September 2005
Est. completion date August 2012

Study information
Verified date August 2012
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients receiving a liver transplant at University of Pittsburgh Medical Center (UPMC) between January 1, 2001 and June 30, 2005.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
University of Pittsburgh Pfizer

Country where clinical trial is conducted

United States, 

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