Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants
Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Amphotericin B Fluconazole Liposomal amphotericin B