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

Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001107
• Other study ID #: DMID 98-014
• Secondary ID: MSG #44
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: August 26, 2010
• Est. completion date: November 2005

Study information

• Verified date: November 2005
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Candidiasis
• Mycoses

Intervention

Drug:
• Fluconazole

• AmBisome

Locations

Country	Name	City	State
United States	Mary Ellen Bradley	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,