Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants
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|ClinicalTrials.gov Identifier: NCT00001107|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : August 27, 2010
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|
|Candidiasis||Drug: Fluconazole Drug: AmBisome||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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|
|Estimated Study Completion Date :||November 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001107
|United States, Alabama|
|Mary Ellen Bradley|
|Birmingham, Alabama, United States, 35294|