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Voriconazole as Prophylaxis for Liver Transplant Recipients

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT00177788
Collaborator
Pfizer (Industry)
800
Enrollment
1
Location
83
Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    800 participants
    Time Perspective:
    Retrospective
    Official Title:
    Voriconazole as Prophylaxis for Liver Transplant Recipients
    Study Start Date :
    Sep 1, 2005
    Actual Primary Completion Date :
    Aug 1, 2012
    Actual Study Completion Date :
    Aug 1, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 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 Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      University of Pittsburgh
      ClinicalTrials.gov Identifier:
      NCT00177788
      Other Study ID Numbers:
      • IRB # 0508150
      First Posted:
      Sep 15, 2005
      Last Update Posted:
      Aug 16, 2012
      Last Verified:
      Aug 1, 2012
      Keywords provided by University of Pittsburgh
      liver transplant
      voriconazole prophylaxis
      liver transplantation
      voriconazole
      Additional relevant MeSH terms:
      Mycoses
      Fungemia

      Study Results

      No Results Posted as of Aug 16, 2012