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
Fluconazole
+ AmBisome
Bacterial Infections and Mycoses+1
+ Infections
+ Mycoses
Prevention Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location