- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00177788
Voriconazole as Prophylaxis for Liver Transplant Recipients
August 14, 2012 updated by: University of Pittsburgh
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 Overview
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
Enrollment (Actual)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
liver transplant patients receiving voriconazole
Description
Inclusion Criteria:
- Patients receiving a liver transplant at University of Pittsburgh Medical Center (UPMC) between January 1, 2001 and June 30, 2005.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (ACTUAL)
August 1, 2012
Study Completion (ACTUAL)
August 1, 2012
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (ESTIMATE)
September 15, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
August 16, 2012
Last Update Submitted That Met QC Criteria
August 14, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB # 0508150
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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