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Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00001107
Collaborator
(none)
500
Enrollment
1
Location

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the safety and effectiveness of 2 treatments to prevent invasive fungal infections (IFI), which are infections caused by yeasts and molds that are common in patients with weak immune systems or transplant patients. AmBisome, a new treatment, will be compared to fluconazole, the traditional treatment for fungal infections caused by the yeast Candida. Treatment will only be given to liver transplant patients who are found to be at high risk for IFI. Liver transplant patients who are at low risk for IFI will be monitored but will receive no study medication.

IFIs are found mainly in a high risk group of liver transplant patients, and are not common in those with low risk. If IFI preventive therapy is focused on the high risk group, there may be a lesser chance of Candida becoming resistant (able to grow despite the presence of drugs used to kill it). Treating only the high risk group will also save money.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

If you are in the high risk group you will be assigned randomly (like tossing a coin) to receive either AmBisome or fluconazole. If you are in the low risk group, you will not receive any treatment. Both groups will be monitored for IFIs. The study will last for 100 days following your liver transplant.

Study Design

Study Type:
Interventional
Masking:
Double
Primary Purpose:
Prevention
Official Title:
Invasive Fungal Infection in Liver Transplant Recipients: A Randomized Double-Blind Trial Comparing AmBisome and Fluconazole in the High Risk Group and an Observational Cohort Study in the Low Risk
Study Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    You may be eligible for this study if you:
    • Have had a liver transplant within 5 days of enrollment and agree to receive tacrolimus.
    Exclusion Criteria:
    You will not be eligible for this study if you:

    • Are HIV-positive.

    • Have a history of invasive fungal infection.

    • Have received antifungal agents within 14 days prior to your liver transplant.

    • Are allergic to azoles, amphotericin B, or tacrolimus.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mary Ellen Bradley Birmingham Alabama United States 35294

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00001107
    Other Study ID Numbers:
    • DMID 98-014
    • MSG #44
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Aug 27, 2010
    Last Verified:
    Nov 1, 2005
    Additional relevant MeSH terms:
    Candidiasis
    Mycoses
    Invasive Fungal Infections
    Fluconazole
    Liposomal amphotericin B

    Study Results

    No Results Posted as of Aug 27, 2010